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

Catalog Number	B1050-080
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Evaluation summary: visual, dimensional and functional analysis was performed on the returned device.The reported deflation issue was not 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 identified no other similar 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.The investigation was unable to determine a conclusive cause for the reported difficulties.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the proximal popliteal artery.Resistance was not felt during advancement of the 5 x 80 mm armada 35 balloon dilatation catheter (bdc) through the lesion and it crossed successfully.The bdc was inflated once to nominal pressure; however, it failed to deflate after several deflation attempts.A 50 ml syringe was used to pull negative pressure for 10 minutes to fully deflate the balloon and the balloon was removed from the anatomy.A replacement bdc was used to complete the procedure.There were no adverse patient effects or clinically significant delay in the procedure reported.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: 6138733
• Report Number: 2024168-2016-08465
• Device Sequence Number: 16367295
• Product Code: LIT
• UDI-Device Identifier: 08717648154621
• UDI-Public: (01)08717648154621(17)190731(10)60209G1
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/01/2016

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: 07/31/2019
• Device Catalogue Number: B1050-080
• Device Lot Number: 60209G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2016
• Initial Report FDA Received Date: 12/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR