MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	1013464-100
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2016
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.(b)(4).Evaluation summary: visual inspections were performed on the returned device.The balloon rupture was confirmed.It is likely that the balloon rupture is the result of interaction with anatomy which was described as heavily calcified.It should be noted that the armada 18 instruction for use states: inflation in excess of the rated burst pressure may cause the balloon to rupture.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 of the reported lot revealed no other incidents.The investigation determined that the reported balloon rupture was due to case circumstances.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 the procedure was to treat a lesion with heavy calcification in the left anterior tibial artery.The 2.5x100 mm armada 18 balloon catheter was prepared accordingly to the instruction for use (ifu) and advanced with no resistance noted to the target lesion.During the first inflation the balloon ruptured at 20 atmosphere (atm).The complete device was withdrawn from the patients anatomy without any complications.A 2.5x150 mm armada 18 balloon catheter was used to complete the procedure.There was no adverse patient effect and no clinically significant information was provided.No additional information was provided.

• Brand Name: ARMADA 18 PTA 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: 6255007
• Report Number: 2024168-2017-00507
• Device Sequence Number: 1004332
• Product Code: LIT
• UDI-Device Identifier: 08717648207808
• UDI-Public: (01)08717648207808(17)190930(10)6040541
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2017

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: 09/30/2019
• Device Catalogue Number: 1013464-100
• Device Lot Number: 6040541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2016
• Initial Report FDA Received Date: 01/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: 6FR TERUMO
• Patient Age: 77 YR
• Patient Weight: 91