MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 35 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	B2050-040
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2017
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 not returned, which may have assisted in determining a root cause.The lot history record was reviewed and identified no exceptions related to this lot for inflation issues or leaks.The complaint history for this lot was reviewed and identified no similar incidents.Based on an expanded evaluation, it was possible that the inflation issue may be related to manufacturing.Manufacturing was notified and corrective actions (if any) will be processed per internal operating procedures.This issue will continue to be monitored.
Event or Problem Description
It was reported that the procedure was to treat a restenosis lesion in the mildly tortuous, mildly calcified, mid femoral artery.A 5.0 x 40 mm armada 35 percutaneous transluminal angioplasty (pta) catheter was selected for the procedure.There was no issue or leak noted during preparation (air aspiration) prior to use.The pta catheter was advanced with no resistance felt to the lesion and the balloon would not inflate.The pta catheter was removed from the anatomy and replaced with a new unspecified balloon catheter to successfully complete the procedure.The physician tested the pta catheter at the preparation table and found that when he tried to inflate the balloon a leak was observed at the area where the proximal shaft and hub connect.There was no reported clinically significant delay in the procedure.There was no reported adverse patient sequela.No additional information provided.

• Brand Name: ARMADA 35 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: 7041357
• Report Number: 2024168-2017-09056
• Device Sequence Number: 11212198
• Product Code: LIT
• UDI-Device Identifier: 08717648155178
• UDI-Public: 08717648155178
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2017

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: 03/31/2020
• Device Catalogue Number: B2050-040
• Device Lot Number: 61026G1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1