MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-24 for SPECTRANETICS BRIDGE OCCLUDING BALLOON CATHETER 590-001 manufactured by The Spectranetics Corporation.
[186722512]
Patient's date of birth unavailable. Patient's weight unavailable. Device lot number, expiration date unavailable. Device manufacture date unavailable because lot number unavailable.
Patient Sequence No: 1, Text Type: N, H10
[186722513]
A lead extraction procedure commenced to remove two leads: a left ventricular (lv) and a right atrial (ra) lead due to occlusion and need for an upgrade. The patient's inr was 1. 9. Prior to the procedure, a spectranetics bridge occluding balloon was prophylactically ''staged'' within the patient's inferior vena cava (ivc). In the event that an emergency occurred during the procedure, the bridge balloon could then be positioned and inflated within the superior vena cava (svc) to provide occlusion of the svc as a rescue measure. When the physician was attempting removal of the lv lead, he used a laser device to aid the extraction from the right side, and then removed the lv lead successfully with a snare from below in the right atrium. The ra lead was also removed successfully. New ra and lv leads were implanted. Use of the bridge balloon was not necessary during the procedure. When the physician was removing the bridge balloon after the procedure, a small thrombus was noted on the bridge balloon. There was no reported patient harm. The manufacturer became aware of this event from a physician presentation and from subsequent conversations with the physician and manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1721279-2020-00062 |
| MDR Report Key | 9875143 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-24 |
| Date of Report | 2020-02-27 |
| Date of Event | 2019-06-24 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-24 |
| 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 BRIDGE OCCLUDING BALLOON CATHETER |
| Generic Name | BRIDGE |
| Product Code | MJN |
| Date Received | 2020-03-24 |
| Model Number | 590-001 |
| Catalog Number | 590-001 |
| Lot Number | UNAVAILABLE |
| 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 | 2020-03-24 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-24 |