MAUDE Adverse Event Report: ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATI

Model Number 1001780-HC

Device Problems Difficult to Insert (1316); Product Quality Problem (1506); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/29/2021

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Date of event is estimated.

Event Description

It was reported through a general comment that as of late, the bmw guide wire stops being pliable and is getting caught on sheath.The guide wire catches on the introducer needle at the point of transition of withdrawn from the needle to reshape.No additional information was provided.

Manufacturer Narrative

The product was not returned to abbott vascular for analysis.A review of the lot history record and similar incident query for this product was not performed since the lot number was not reported.The investigation was unable to determine a conclusive cause for the reported irregular appearance, difficulty to insert and difficulty to remove.Based on the reported information, it is possible that during tip shape process prior to use, the guide wire was over shaped and/or bent resulting in the reported difficulties; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATI
• Type of Device: GUIDE WIRE
• MDR Report Key: 12527046
• MDR Text Key: 273152300
• Report Number: 2024168-2021-08552
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08717648025969
• UDI-Public: 08717648025969
• Combination Product (y/n): N
• PMA/PMN Number: K021228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1001780-HC
• Device Catalogue Number: 1001780-HC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SHEATH; SHEATH