Devices › Device, removal, pacemaker electrode, percutaneous
Device brand name · Device removal pacemaker electrode percutaneous
GlideLight Laser Sheath: medical device reports filed with FDA
308 reports name it, 2012–2026. Manufacturer given most often on reports: Spectranetics. Product code MFA.
- 308
- device reports naming the brand
- 0% of all MAUDE reports · about 21 a year
- 118
- reports, 12 months to August 2026
- 63 in the 12 months before
- 13.3%
- classified as malfunction
- 7.3% across the product code
- 29.2%
- classified as death, as reported
- 90 reports · not verified by FDA
308 medical device reports received by FDA name the brand "GlideLight Laser Sheath" (device removal pacemaker electrode percutaneous); the manufacturer given most often on reports is Spectranetics; received from January 2012 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
118 reports arrived in the 12 months to August 2026, up 87% from 63 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (57.5%), death (29.2%) and malfunction (13.3%); across all device, removal, pacemaker electrode, percutaneous reports (product code MFA) death is recorded in 32.6% and malfunction in 7.3%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are material separation (12.3%), insufficient device problem information (4.2%) and physical resistance (2.6%). The patient problems coded most often are great vessel perforation, pericardial effusion and cardiac perforation. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 1,566 reports carrying product code MFA. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Material separation | 38 | 12.3% | 2.6% |
| Insufficient device problem information | 13 | 4.2% | 20.3% |
| Physical resistance | 8 | 2.6% | 2.3% |
| Entrapment of device | 3 | 1% | 1.1% |
| Fracturea broken bone | 3 | 1% | 1.9% |
| Deformation due to compressive stress | 2 | 0.6% | 0.5% |
| Difficult to removethe device was hard to remove | 2 | 0.6% | 3.5% |
| Impedance problem | 2 | 0.6% | 0.1% |
| Breakthe device broke | 1 | 0.3% | 3.6% |
| Device abrasion from instrument or another object | 1 | 0.3% | 0% |
| Failure to advance | 1 | 0.3% | 2.9% |
| Failure to disconnect | 1 | 0.3% | 0% |
| Material perforation | 1 | 0.3% | 0.2% |
| Material protrusion/extrusion | 1 | 0.3% | 0.1% |
| Material split, cut or torn | 1 | 0.3% | 0.4% |
| Migration or expulsion of device | 1 | 0.3% | 0.3% |
| Positioning failure | 1 | 0.3% | 0.1% |
| Sharp edges | 1 | 0.3% | 0.1% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Great vessel perforation | 147 | 47.7% |
| Pericardial effusionfluid around the heart | 77 | 25% |
| Cardiac perforation | 56 | 18.2% |
| Perforation of vessels | 53 | 17.2% |
| Unintended radiation exposure | 38 | 12.3% |
| Low blood pressure/ hypotension | 26 | 8.4% |
| Laceration(s) | 16 | 5.2% |
| Hemorrhage/blood loss/bleeding | 15 | 4.9% |
| Deaththe patient died; cause not stated by this term | 13 | 4.2% |
| Pleural effusionfluid around the lung | 10 | 3.2% |
| Cardiac tamponade | 8 | 2.6% |
| Hematomaa collection of blood under the skin or in tissue | 6 | 1.9% |
| Hemothorax | 6 | 1.9% |
| Sepsisa severe body-wide response to infection | 6 | 1.9% |
| Cardiac arrestthe heart stopped | 4 | 1.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | GlideLight Laser Sheath | Product code MFA | All MAUDE reports |
|---|---|---|---|
| Reports | 308 | 1,566 | 26,136,888 |
| Share of that pool | — | 19.7% | 0% |
| Classified as death, per 1,000 reports | 292 | 326 | 9 |
| Classified as injury | 57.5% | 59.4% | 36.2% |
| Classified as malfunction | 13.3% | 7.3% | 62.3% |
| Filed by the manufacturer | 100% | 97.8% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code MFA
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Spectranetics Glidelight Laser Sheath | 452 | 0 | 33.2% |
| Spectranetics 16f Glidelight Laser Sheath | 162 | 0 | 32.7% |
| Spectranetics Lead Locking Device | 689 | 0 | 6.5% |
| Spectranetics Tightrail Rotating Dilator Sheath | 171 | 0 | 21.1% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about GlideLight Laser Sheath reports
How many FDA reports name GlideLight Laser Sheath?
308 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 118 in the latest 12 months.
What kinds of events are reported?
injury (57.5%), death (29.2%) and malfunction (13.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material separation (12.3%), insufficient device problem information (4.2%), physical resistance (2.6%), entrapment of device (1%) and fracture (1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that GlideLight Laser Sheath was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.