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

Model Number 1003327

Device Problem Break (1069)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762)

Event Date 06/21/2020

Event Type  Injury  

Manufacturer Narrative

The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that this was a percutaneous coronary intervention procedure in the left anterior descending coronary artery.The non-abbott balloon dilatation catheter (bdc) was connected to the indeflator.The bdc was inflated, but it failed to deflate.The same indeflator had been used with another device and was successfully used.With this bdc, it remained inflated for ten seconds.The patient became bradycardic and required cardiopulmonary resuscitation.Atropine was administered and the patient was stabilized.Another indeflator from the same lot was connected to the bdc and was able to successfully deflate.The procedure continued and a stent was implanted.There was no additional information provided.

Manufacturer Narrative

The device was not returned for analysis.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 similar incidents from this lot.The investigation determined a conclusive cause for the reported break/unable to deflate cannot be determined.The reported difficulties possibly contributed to the reported patient effects however a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: INDEFLATOR PPAK 20/30
• Type of Device: ACCESSORIES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10264534
• MDR Text Key: 198541534
• Report Number: 2024168-2020-05712
• 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: 09/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 1003327
• Device Catalogue Number: 1003327
• Device Lot Number: 60228844
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/13/2020
• Supplement Dates Manufacturer Received: 08/26/2020
• Supplement Dates FDA Received: 09/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 60