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

Catalog Number	A1040-080
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Evaluation summary: visual and functional inspections were performed on the returned device.The leak was confirmed.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 was unable to determine a conclusive cause for the leak.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 during predilatation in the heavily calcified, very stenotic, common femoral artery, during the first inflation at 8 atmospheres (atm) for 30 seconds, a leak in the hub was noticed.The device was removed and replaced with a non-abbott balloon to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.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: 6356999
• Report Number: 2024168-2017-01497
• Device Sequence Number: 13462505
• Product Code: LIT
• UDI-Device Identifier: 08717648155871
• UDI-Public: (01)08717648155871(17)180930(10)5041441
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/24/2017

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: 09/30/2018
• Device Catalogue Number: A1040-080
• Device Lot Number: 5041441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2017
• Initial Report FDA Received Date: 02/24/2017
• 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 WIRE: COMMAND 014 ES