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

Catalog Number	B2060-040
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2016
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.Visual inspections were performed on the returned device.The reported difficulties were confirmed.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.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 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 moderately tortuous and heavily calcified left external iliac.A 6.0 x 40 mm armada 35 catheter was being used for pre-dilatation and was inflated 3 times to 6 atmospheres and then pressurized to 9 atmospheres when the balloon ruptured and separated into two pieces.The entire system: sheath, guide wire and balloon catheter, with the separated piece included, was removed from the anatomy as a single unit.An asahi prowater 300 guide wire was being used in the procedure and after removal from the anatomy, it was found that the coils were stretched out.There was no resistance reported.A new sheath was placed and an unspecified stent was deployed to successfully complete the procedure.There were no adverse patient effects or 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: 6055500
• Report Number: 2024168-2016-07287
• Device Sequence Number: 13675508
• Product Code: LIT
• UDI-Device Identifier: 08717648155260
• UDI-Public: (01)08717648155260(17)190630(10)60129G1
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 10/25/2016

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: 06/30/2019
• Device Catalogue Number: B2060-040
• Device Lot Number: 60129G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2016
• Initial Report FDA Received Date: 10/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE: ASAHI PROWATER
• Patient Age: 83 YR