MAUDE Adverse Event Report: ABBOTT VASCULAR GUIDE WIRE ACC.KIT W/COPILOT; ACCESSORIES

Model Number 1003330

Device Problem Leak/Splash (1354)

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

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat a mildly tortuous, mildly calcified right coronary artery.There was a lot of bubbles noted at the tubing that connected to the co-pilot.It was confirmed that there was no connection issue, however it was still decided to change to another new co-pilot which successfully completed the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported leak was unable to be confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.As the reported leak was unable to be confirmed during return analysis, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that the device was not fully connected and/or the device seals were not fully tightened/closed thus resulting in the reported leak.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.

• Brand Name: GUIDE WIRE ACC.KIT W/COPILOT
• Type of Device: ACCESSORIES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12546849
• MDR Text Key: 273783237
• Report Number: 2024168-2021-08725
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 08717648013980
• UDI-Public: 08717648013980
• Combination Product (y/n): N
• PMA/PMN Number: K991102
• 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: 10/28/2021

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: 01/31/2023
• Device Model Number: 1003330
• Device Catalogue Number: 1003330
• Device Lot Number: 60281958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Initial Date Manufacturer Received: 09/10/2021
• Initial Date FDA Received: 09/29/2021
• Supplement Dates Manufacturer Received: 10/25/2021
• Supplement Dates FDA Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1