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

Catalog Number	1013468-200
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/29/2016
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.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 incidents from this lot.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.The investigation was unable to determine a conclusive cause for the reported balloon rupture.
Event or Problem Description
It was reported the procedure was to treat a lesion with moderate calcification in the superficial femoral artery (sfa).The armada 18 balloon catheter was advanced to the target lesion with no resistance noted.During inflation of the armada 18, a pinhole was noted in the balloon at 6 atmospheres.The device was removed without any issues and a new armada 18 was used in the procedure successfully.There was no adverse patient effect and no clinically significant delay in the procedure.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: 5937211
• Report Number: 2024168-2016-05937
• Device Sequence Number: 794283
• Product Code: LIT
• UDI-Device Identifier: 08717648208249
• UDI-Public: (01)08717648208249(17)191231(10)6070441
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/08/2016

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: 12/31/2019
• Device Catalogue Number: 1013468-200
• Device Lot Number: 6070441
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2016
• Initial Report FDA Received Date: 09/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1