MAUDE Adverse Event Report: ABBOTT VASCULAR 20/30 PRIORITY PACK INDEFLATOR; ACCESSORIES

Model Number 1003327

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The other two devices referenced are filed under separate medwatch report numbers.

Event Description

It was reported that the procedure was to treat a chronic total occlusion (cto) patient and lesion located in the right coronary artery.The lesion was a mid to distal long cto lesion.The junction where the copilot screws on to the guide catheter kept unscrewing and would not connect.This happened three times.A new copilot was used to continue the procedure.There were no reported 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 loose or intermittent connection was unable to be confirmed.The returned guiding catheter was connected to the copilot bleedback control valve (bbcv) rotator, forming a secure connection.There were no anomalies noted to the connections as reported.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 loose or intermittent connection 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 a buildup of procedural contaminants (blood, contrast) on the device and/or the device was not completely connected/fully tightened thus resulted in the reported loose connection.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: 20/30 PRIORITY PACK INDEFLATOR
• Type of Device: ACCESSORIES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 11152844
• MDR Text Key: 226315231
• Report Number: 2024168-2021-00330
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08717648013973
• UDI-Public: 08717648013973
• Combination Product (y/n): N
• PMA/PMN Number: K961471
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/05/2021

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: 08/31/2022
• Device Model Number: 1003327
• Device Catalogue Number: 1003327
• Device Lot Number: 60259848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/11/2021
• Supplement Dates Manufacturer Received: 01/27/2021
• Supplement Dates FDA Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LAUNCHER GUIDE CATHETER; LAUNCHER GUIDE CATHETER