MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-01-14 for SPECTRANETICS 14F GLIDELIGHT LASER SHEATH 500-302 manufactured by The Spectranetics Corporation.
[177008911]
In the spectranetics glidelight laser sheath instructions for use (ifu), 4. Warnings, it states ''do not advance the laser sheath any closer than 1 cm from the lead tip. Do not lase at the myocardium to free the lead tip".
Patient Sequence No: 1, Text Type: N, H10
[177008912]
A lead extraction procedure commenced to remove two leads: a right atrial (ra) lead and a right ventricular (rv) lead due to non function. This was a young patient that was pacemaker dependent. The physician successfully removed the rv lead with no complications, and then attempted to remove the ra lead. Using a spectranetics 14f glidelight laser sheath and a lead locking device (lld), lasing began with successful advancement to the end of the ra lead but it did not release from the tissue. Along with applying traction, the physician advanced the glidelight laser sheath distal tip beyond the tip of the lead. The lead came out successfully with no initial change in blood pressure. Approximately 2-3 minutes later the patient's blood pressure began to drop and a pericardial effusion was seen with use of transesophageal echocardiography(tee). Rescue efforts commenced immediately, and a right atrial perforation was discovered. The repair was successful and the patient survived the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2020-00014 |
| MDR Report Key | 9587560 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-01-14 |
| Date of Report | 2019-12-19 |
| Date of Event | 2019-12-16 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2019-12-19 |
| Date Added to Maude | 2020-01-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. BARBARA CREEL |
| Manufacturer Street | 9965 FEDERAL DRIVE |
| Manufacturer City | COLORADO SPRINGS CO 80921 |
| Manufacturer Country | US |
| Manufacturer Postal | 80921 |
| Manufacturer Phone | 719447-246 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPECTRANETICS 14F GLIDELIGHT LASER SHEATH |
| Generic Name | GLIDELIGHT |
| Product Code | MFA |
| Date Received | 2020-01-14 |
| Model Number | 500-302 |
| Catalog Number | 500-302 |
| Lot Number | FGB19K03A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THE SPECTRANETICS CORPORATION |
| Manufacturer Address | 9965 FEDERAL DRIVE COLORADO SPRINGS CO 80921 US 80921 |
| Product Code | --- |
| Date Received | 2020-01-14 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-01-14 |