MAUDE Adverse Event Report: AV-TEMECULA-CT RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER

Catalog Number	1008189-20
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.The investigation determined that the reported balloon rupture appears to be related to case circumstances.The balloon rupture was likely the result of interaction with the heavily calcified lesion.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the procedure was performed to treat a heavily calcified lesion in the right common iliac artery.The 4.0 x 20 mm viatrac dilatation catheter was advanced to the target lesion without issue.During the first inflation to 10 atmospheres, the balloon ruptured.The device was removed without issue.The target lesion was stented and ballooned.There was no reported adverse patient effect or a clinically significant delay.No additional information was provided.

• Brand Name: RX VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8203829
• Report Number: 2024168-2018-10083
• Device Sequence Number: 16212432
• Product Code: LIT
• UDI-Device Identifier: 08717648056826
• UDI-Public: 08717648056826
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/28/2018

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: 10/31/2020
• Device Catalogue Number: 1008189-20
• Device Lot Number: 8110661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 90