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

Catalog Number	B1080-080
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/13/2017
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 inflation issue and balloon rupture were confirmed.It is likely that the reported balloon rupture occurred due to interaction with the lesion site.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 no other similar incidents for this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.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 an armada balloon was treating an upper arm fistula with moderate calcification.The device advanced without an issue to the treatment site and inflation was attempted.The balloon failed to inflate and a hole in the device was suspected.The device was removed without issue.There were no adverse patient effects and there was no clinically significant procedural delay.Another device used in replacement.There was 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: 6541261
• Report Number: 2024168-2017-03865
• Device Sequence Number: 16176337
• Product Code: LIT
• UDI-Device Identifier: 08717648154881
• UDI-Public: (01)08717648154881(17)180930(10)50420G1
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/03/2017

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: B1080-080
• Device Lot Number: 50420G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2017
• Initial Report FDA Received Date: 05/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1