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

Catalog Number	B2050-200
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2017
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: visual inspection was performed on the returned device.The reported balloon rupture was confirmed.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history revealed there is no indication of a lot specific product issue.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 left superficial femoral artery that was mildly tortuous, highly calcified and 60% stenosed.The armada 35 balloon burst after the first inflation below rated burst pressure.Another armada 35 was used to complete the procedure.The device was prepped according to the instructions for use with no issues or leaks noted.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was 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: 6575589
• Report Number: 2024168-2017-04252
• Device Sequence Number: 557374
• Product Code: LIT
• UDI-Device Identifier: 08717648155239
• UDI-Public: (01)08717648155239(17)190930(10)60429G1
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K111899
• 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): 05/18/2017

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: 09/30/2019
• Device Catalogue Number: B2050-200
• Device Lot Number: 60429G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2017
• Initial Report FDA Received Date: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR