MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	A2020-060
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2018
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.A visual inspection was performed on the returned device.The reported balloon rupture was confirmed.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 reported from this lot.The investigation determined the reported balloon rupture appears to be related to circumstances of the procedure.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 lesion in the anterior tibial artery.An attempt was made to inflate the 2.0 x 60 mm armada dilatation catheter balloon.However, it was noted that the device would not hold pressure and a hole in the balloon was suspected.The device was removed without difficulty and a second armada was used without issue.There was no adverse patient effect and no clinically significant delay.No additional information was provided.

• Brand Name: ARMADA 14 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: 7610073
• Report Number: 2024168-2018-04536
• Device Sequence Number: 1897998
• Product Code: LIT
• UDI-Device Identifier: 08717648155963
• UDI-Public: 08717648155963
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/18/2018

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: 05/31/2021
• Device Catalogue Number: A2020-060
• Device Lot Number: 7121841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 06/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1