SPECTRANETICS BRIDGE OCCLUDING BALLOON CATHETER 590-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-25 for SPECTRANETICS BRIDGE OCCLUDING BALLOON CATHETER 590-001 manufactured by The Spectranetics Corporation.

Event Text Entries

[186722740] Patient date of birth unavailable. Patient weight unavailable. Device lot number and expiration date unavailable. Device manufacture date unavailable because lot number is unavailable.
Patient Sequence No: 1, Text Type: N, H10

[186722741] A lead extraction procedure commenced to remove three leads (locations unknown) due to fungemia (presence of yeasts or fungi in the blood). 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. It was noted that there was significant vegetation present on the leads, along with the leads being bound to each other in the superior vena cava (svc). The physician used a spectranetics 16f glidelight laser sheath to aid in lead removal, and sutures to provide traction for the leads. At one point, the physician had to pull all the leads to keep them straight during extraction attempts. The physician switched back and forth between the leads during the procedure. The sutures came off the lead conductors and insulation during the procedure, so when the glidelight reached the rv lead coil, the lead began to snowplow (when the lead bunches up on itself, making lead removal more difficult). Re-engaging the leads helped in the extraction attempts, and ultimately all leads were successfully removed. Use of the bridge balloon was not necessary during the lead extraction procedure. When the bridge balloon was removed from the body after the procedure, the physician noted a large thrombus 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

MAUDE Entry Details

• Report Number: 1721279-2020-00069
• MDR Report Key: 9878388
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2020-03-25
• Date of Report: 2020-02-27
• Date of Event: 2019-08-14
• 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: 2020-03-25
• 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

Device Sequence Number: 1

• Brand Name: SPECTRANETICS BRIDGE OCCLUDING BALLOON CATHETER
• Generic Name: BRIDGE
• Product Code: MJN
• Date Received: 2020-03-25
• 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

Device Sequence Number: 101

• Product Code: ---
• Date Received: 2020-03-25
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2020-03-25