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

Model Number 1000184

Device Problems Break (1069); Leak/Splash (1354); Noise, Audible (3273)

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

Event Date 02/17/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that during an unspecified procedure, when inflating a trek balloon dilatation catheter to 14 atmospheres, the indeflator line broke, a noise was heard and a leak was noted.There was no adverse patient effect or a clinically significant delay in procedure.Another device was used to complete the procedure.No additional information was provided.

Manufacturer Narrative

The device was returned for analysis.The reported break was able to be confirmed.The reported leak and noise were unable to be replicated in a testing environment due to the condition of the returned device.It was noted that the face plate top tabhad an indentation and the faceplate, the gauge and the screen were separated from the indeflator housing.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.It is possible that inadvertent mishandling during shipment and/or during preparation for use resulted in the noted face plate top tab indentation; thus compromising the indeflator such that during inflation resulted in the reported break/noted faceplate/gauge/screen breaks; however this cannot be confirmed.The investigation determined a conclusive cause for the reported/noted breaks cannot be determined.The reported leak and reported noise were likely a result of the reported/noted device breaks.There is no indication of a product quality issue with respect to manufacture, design or labeling.Na.

• Brand Name: 20/30 PRIORITY PACK INDEFLATOR
• Type of Device: ACCESSORIES
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16535066
• MDR Text Key: 311219902
• Report Number: 2024168-2023-02636
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08717648013591
• UDI-Public: 08717648013591
• Combination Product (y/n): N
• Reporter Country Code: CS
• PMA/PMN Number: K961471
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

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: 05/31/2024
• Device Model Number: 1000184
• Device Catalogue Number: 1000184
• Device Lot Number: 60374476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2023
• Initial Date FDA Received: 03/13/2023
• Supplement Dates Manufacturer Received: 03/27/2023
• Supplement Dates FDA Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1