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

Catalog Number	B2060-100
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Evaluation summary: visual and functional analysis 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 identified no other incidents from this lot.Based on the information reviewed, 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 superficial femoral artery that was heavily calcified.For pre-dilatation, an armada 35 balloon dilatation catheter was used, however, during the first inflation, the balloon ruptured at 10 atmospheres.A non-abbott balloon dilatation catheter was used to successfully complete the procedure.There were no reported adverse patient effect and no 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: 5925192
• Report Number: 2024168-2016-05891
• Device Sequence Number: 19189011
• Product Code: LIT
• UDI-Device Identifier: 08717648155291
• UDI-Public: (01)08717648155291(17)190331(10)51031G1
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/02/2016

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: 03/31/2019
• Device Catalogue Number: B2060-100
• Device Lot Number: 51031G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2016
• Initial Report FDA Received Date: 09/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 88