MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE WHISPER WIRE; WIRE, GUIDE, CATHETER

Lot Number 0031071

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems Hematoma (1884); Foreign Body In Patient (2687)

Event Date 07/30/2020

Event Type  Injury  

Event Description

In attempts to declott a left fistula, the physician used a whisper wire; the whisper wire broke off in the fistula; this was removed; the patient then developed a large hematoma and was taken to the operating room.Fda safety report id# (b)(4).

• Brand Name: HI-TORQUE WHISPER WIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 10493848
• MDR Text Key: 205915258
• Report Number: MW5096430
• Device Sequence Number: 1
• Product Code: DQX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Lot Number: 0031071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 62