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

Model Number 1003327

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during the procedure, a 20/30 indeflator inflated but could not deflate an unspecified balloon.There were no adverse patient effects and no clinically significant delay in the procedure.A new device was used to deflate the balloon and successfully complete the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported break was able to be confirmed.Additionally, a crack was observed on the back side at the proximal end of the hose assembly port, and a leak was observed 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 reportedly during the procedure the indeflator properly inflated the balloon, it is possible that inadvertent mishandling during deflation resulted in the reported break/noted observed crack on the back side at the proximal end of the hose assembly port; however this cannot be confirmed.The noted leak is a direct result of the reported/noted break.The investigation determined a conclusive cause for the reported/noted difficulties cannot be determined.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: 11113734
• MDR Text Key: 225117468
• Report Number: 2024168-2021-00057
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

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: 06/30/2022
• Device Model Number: 1003327
• Device Catalogue Number: 1003327
• Device Lot Number: 60247877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 02/01/2021
• Supplement Dates FDA Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1