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

Catalog Number	A2020-040
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2017
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.Evaluation summary: the device was returned.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 similar 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 the procedure was to treat a lesion located in the lower extremity.During inflation of the 2.0 x 40 mm armada balloon catheter balloon at the lesion the pressure was unstable.As the correct pressure could not be reached the balloon catheter was removed from the patient.After retraction of the shaft of the device was observed to be leaking close to the guide wire exit notch.There was no resistance felt during advancement of the balloon catheter to the lesion.Another balloon catheter was used to complete the case.No adverse patient effects or clinically significant delay in the procedure were reported.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: 6888000
• Report Number: 2024168-2017-07694
• Device Sequence Number: 10794309
• Product Code: LIT
• UDI-Device Identifier: 08717648155956
• UDI-Public: 08717648155956
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 09/22/2017

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: A2020-040
• Device Lot Number: 5043041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 09/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1