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

Model Number	1008201-20
Medical Device Problem Codes	Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not returned for evaluation.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.It was reported by the account that during inflation, the balloon was overinflated to 24 atmospheres (atms) and the balloon ruptured.It should be noted that the peripheral dilatation catheter (pdc), viatrac 14 plus, global, instruction for use (ifu) states: balloon pressure should not exceed the rated burst pressure (rbp).The rbp for the rx viatrac plus device is 14 atm; therefore, rbp was exceeded.In this case, it is likely the ifu deviation resulted in the reported balloon rupture.The investigation determined the reported balloon rupture appears to be related to user error.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.The absolute pro and armada 35 devices referenced are filed under separate medwatch report numbers.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified, 98% stenosed lesion in the left external iliac artery.A 9x100mm absolute pro vascular self-expanding stent system (sess) was implanted without issue.During post-dilatation, while advancing with a 9x80mm armada 35 balloon dilatation catheter (bdc), the physician pushed the edge of the tip of the armada bdc against the implanted absolute pro stent causing resistance between the devices, and the absolute pro sess became stretched.The bdc was removed and replaced with a viatrac 14 plus peripheral balloon dilatation catheter to complete post-dilatation, when the balloon was inflated to 24 atmospheres (atm) and ruptured on the first inflation.The viatrac bdc was removed and the armada bdc was re-inserted to successfully complete the post-dilatation.The stretched absolute sess remains implanted.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
• Common Device Name: 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: 15263279
• Report Number: 2024168-2022-08965
• Device Sequence Number: 5977719
• Product Code: LIT
• UDI-Device Identifier: 08717648057304
• UDI-Public: 08717648057304
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K072798
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: 1008201-20
• Device Catalogue Number: 1008201-20
• Device Lot Number: 1081761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 08/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 67 KG