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

Catalog Number	B2100-040
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2018
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 other three armada devices are being filed under separate medwatch reports.Evaluation summary: visual inspection was performed on the returned device.The reported balloon rupture was confirmed.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 incidents.The investigation determined the reported balloon rupture appears to be related to circumstances of the procedure.It is likely that the reported balloon rupture occurred due to interaction with anatomy or associated devices.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The used 20/30 indeflator was also returned and tested.There was no damage or pressurization issues noted.
Event or Problem Description
It was reported that the procedure was to treat an arteriovenous fistula.A 10x40mmx135cm armada 35 balloon dilatation catheter (bdc) was advanced to the target lesion without issue, however during the first inflation to 4 atmospheres (atm), the balloon ruptured.A second 10x40mmx135cm armada 35 bdc also ruptured at 4 atm.A 10x40mmx80cm armada 35 bdc ruptured at 6 atm, and a 12x40mmx80cm armada 35 bdc ruptured at 4 atm.Although no damage was seen on the indeflator, it was stated there could be an issue with the indeflator, since the four balloons ruptured during inflation with the same indeflator.A new indeflator and an unspecified bdc were used without further issues to complete the procedure.There were no adverse patient effects and 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: 7847374
• Report Number: 2024168-2018-06889
• Device Sequence Number: 16527875
• Product Code: LIT
• UDI-Device Identifier: 08717648155512
• UDI-Public: 08717648155512
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/05/2018

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: 12/31/2020
• Device Catalogue Number: B2100-040
• Device Lot Number: 70720G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1