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

Catalog Number	B2060-250
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/12/2017
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.(b)(4).Evaluation summary: visual, dimensional and functional analysis was performed on the returned device.The reported deflation issue was unable to be confirmed due to the separation.The separation and difficulty removing from the introducer sheath was confirmed.It should be noted that the instruction for use states: carefully inspect the catheter prior to use to verify that it has not been damaged during shipment and that its size, shape and condition are suitable for the procedure for which it is to be used.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that contributed to this event.Additionally, a review of the complaint history revealed no other incidents.The investigation was unable to determine a conclusive cause for the reported difficulties.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 calcified proximal superficial femoral artery.During the first attempt to inflate and deflate a 6.0 x 250 mm armada 35 balloon catheter the balloon inflated and deflated holding negative 3-5 seconds; however, the balloon would not fully deflate.The balloon catheter was removed partially deflated.The same balloon catheter was used to treat a different lesion, was inserted, not inflated and then removed still partially deflated.During removal, the balloon separated from the introducer sheath with a piece of the balloon stuck inside the sheath.The device was removed as a single unit with a balloon portion still inside the sheath.Another balloon and sheath were used to successfully complete the procedure.There was no clinically significant delay in procedure and no adverse patient effects.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: 7000150
• Report Number: 2024168-2017-08651
• Device Sequence Number: 1156375
• Product Code: LIT
• UDI-Device Identifier: 08717648155338
• UDI-Public: 08717648155338
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 11/03/2017

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: 01/31/2021
• Device Catalogue Number: B2060-250
• Device Lot Number: 70822G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2017
• Initial Report FDA Received Date: 11/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1