MAUDE Adverse Event Report: ABBOTT VASCULAR RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER; PEREIPHERAL DILATATION CATHETER

Catalog Number 1008193-30

Device Problems Failure to Fold (1255); Difficult to Remove (1528)

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

Event Date 09/19/2023

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 the procedure was to treat a 70% stenosed de novo lesion in the iliac artery with mild calcification and mild tortuosity.The 5.0x30mm viatrac plus balloon dilatation catheter (bdc) was advanced to the target lesion and the balloon was inflated one time to 10 atmospheres.Negative pressure was held for 5 seconds to deflate the balloon, and although the balloon completely deflated, it did not rewrap/refold tightly.There was difficulty removing the bdc due to the poor refold; therefore, the bdc was removed together with the sheath as a single unit.There was no adverse patient effect and no clinically significant delay reported in the procedure.Another viatrac balloon was used in the procedure.No additional information was provided.

Manufacturer Narrative

Visual inspection was performed on the returned device.The reported failure to fold (winged balloon) was confirmed.The reported difficulty removing the device from the introducer sheath could not be replicated in a testing environment due to the condition of the returned device.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 and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported failure to fold (winged balloon); however, the reported difficulty removing the device appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
• Type of Device: PEREIPHERAL DILATATION CATHETER
• 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: 17909437
• MDR Text Key: 325339087
• Report Number: 2024168-2023-11175
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648056994
• UDI-Public: 08717648056994
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K072798
• 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: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1008193-30
• Device Lot Number: 3041961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2023
• 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