MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2020-03-23 for SPECTRANETICS BRIDGE OCCLUDING BALLOON CATHETER 590-001 manufactured by The Spectranetics Corporation.
[186722299]
Patient date of birth unavailable. Patient weight unavailable. Device lot number, expiration date unavailable. Device manufacture date unavailable because lot number unavailable.
Patient Sequence No: 1, Text Type: N, H10
[186722300]
A lead extraction procedure commenced to remove two leads: a right ventricular (rv) and a right atrial (ra) lead due to bacteremia. 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. The procedure was completed successfully using traction, with no reported patient harm. Vegetation was noted on both of the leads at the time of lead removal. Use of the bridge balloon was not necessary. When the bridge balloon was removed from the body after the procedure, the physician noted significant thrombus formation on the bridge balloon. Three days post procedure, the patient experienced a pulmonary embolism. 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 | 1721279-2020-00059 |
| MDR Report Key | 9869460 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2020-03-23 |
| Date of Report | 2020-02-27 |
| Date of Event | 2019-07-11 |
| 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 | 2020-03-23 |
| 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 | 2020-03-23 |
| 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 | 2020-03-23 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-23 |