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	03/15/2017
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 lesion in the moderately tortuous, moderately calcified left superficial femoral artery (sfa).A 5.0 x 200 mm armada 18 percutaneous transluminal angioplasty (pta) catheter was selected for the procedure.The pta catheter was advanced with no resistance to the lesion, but upon inflation of the balloon, contrast was observed coming from the balloon.Despite the leak the lesion was successfully dilated and the pta catheter was removed from the anatomy.There was no reported clinically significant delay in the procedure.There was no reported adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Evaluation summary: abbott vascular (av) analyzed the returned device and determined that the leak was at the distal end of the hub, not the balloon as reported.A review of the complaint handling database found one similar incident from this lot.Av reviewed the lot history record and there were no manufacturing nonconformities that would have contributed to this complaint.Av 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: 6476012
• Report Number: 2024168-2017-02954
• Device Sequence Number: 19045081
• Product Code: LIT
• UDI-Device Identifier: 08717648208249
• UDI-Public: (01)08717648208249(17)191231(10)6070441
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 05/09/2017

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: 12/31/2019
• Device Catalogue Number: 1013468-200
• Device Lot Number: 6070441
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/30/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/16/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2017
• Supplement Report FDA Received Date: 05/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 88