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

Model Number 1000184

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/25/2020

Event Type  malfunction  

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 the procedure was to treat a heavily tortuous lesion.Negative was held with the 20/30 indeflator, for 15 seconds, in an attempt to deflate a non-abbott balloon.Difficulty was noted deflating the balloon and high resistance was noted when turning the handle.There was no adverse patient effect and no clinically significant delay in the procedure.Another indeflator was used to complete the procedure.No additional information was 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 indicated a lot specific quality issue could not be determined.As the device was not returned, the investigation was unable to determine a conclusive cause for the reported difficulties.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: 9969504
• MDR Text Key: 188096812
• Report Number: 2024168-2020-03711
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08717648013591
• UDI-Public: 08717648013591
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 05/15/2020

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: 03/31/2020
• Device Model Number: 1000184
• Device Catalogue Number: 1000184
• Device Lot Number: 60119725
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/25/2020
• Initial Date FDA Received: 04/16/2020
• Supplement Dates Manufacturer Received: 04/29/2020
• Supplement Dates FDA Received: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALLOON CATHETER