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

Catalog Number	1013468-100
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2017
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 received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a moderately calcified popliteal artery.A 5.0x 100 mm armada 18 balloon catheter was advanced to the lesion; however, when attempting to inflate the balloon there was a leak at the strain relief tubing.Another armada 18 was successfully used to complete the procedure.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Evaluation summary: abbott vascular (av) analyzed the returned device and confirmed the reported leak in the distal end of the hub.A review of the complaint handling database found no other incident from this lot.Av reviewed the lot history record and there were no manufacturing nonconformities that would have contributed to this complaint.Av conducted root cause and determined the most probable root cause is variability in the gluing process during manufacturing.The issue will be addressed per internal operating procedures.Av will continue to trend the performance of these devices.

• 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: 6533953
• Report Number: 2024168-2017-03796
• Device Sequence Number: 133707
• Product Code: LIT
• UDI-Device Identifier: 08717648208201
• UDI-Public: (01)08717648208201(17)200531(10)6121941
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,Followup
• Report Date (Section B): 05/10/2017

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: 05/31/2020
• Device Catalogue Number: 1013468-100
• Device Lot Number: 6121941
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/20/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2017
• Supplement Report FDA Received Date: 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR