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

Catalog Number	1013468-040
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.A review of the lot history records revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lots revealed no other incidents.The investigation determined the reported difficulties were likely due to case circumstances.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 the armada 018 balloon dilatation catheter became stuck on the 018 steel core guide wire during advancement to the uncalcified, non-tortous popliteal artery.The armada 018 was unable to be removed from the guide wire, so both were removed from the anatomy as a unit.Outside the anatomy, the devices were removed from each other.The same guide wire was used with a new armada 018 to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.There was no additional information 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: 7430666
• Report Number: 2024168-2018-02782
• Device Sequence Number: 1340232
• Product Code: LIT
• UDI-Device Identifier: 08717648208171
• UDI-Public: 08717648208171
• 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): 04/13/2018

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: 01/31/2021
• Device Catalogue Number: 1013468-040
• Device Lot Number: 7080141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1