MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	A2015-120
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The command guide wire referenced is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a moderately tortuous, moderately calcified popliteal artery (btk-below the knee).The lesion was recanalized successfully with the tip of the command guide wire (gw) in the ateria dorsalis pedis.An armada 14 balloon was then used to treat the lesion in the btk area.During advancing the balloon, resistance was met with the command gw.It was then attempted to stretch the gw to assist in advancing the balloon easier.The balloon was then able to advance over the guide wire and be inflated at the lesion.As the gw was attempted to be removed, they noted the tip of the wire was not moving because it had become separated.Then during attempted removal of the armada, the balloon catheter got twisted in itself and it was not able to be removed through the 6f sheath.It was noted that resistance was met with the gw as well.It was then decided to remove the gw, balloon and sheath altogether as a single unit.The procedure was deemed incomplete.The next day a re-intervention with a snare device was done to remove the separated tip.It was noted that the tip was kinked.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.Return of the balloon catheter may have further aided the analysis.However, the associated guidewire was returned for examination.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 reported from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ARMADA 14 PTA CATHETER
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9664398
• Report Number: 2024168-2020-01163
• Device Sequence Number: 502348
• Product Code: DQY
• UDI-Device Identifier: 08717648155932
• UDI-Public: 08717648155932
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

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: 07/31/2020
• Device Model Number: A2015-120
• Device Catalogue Number: A2015-120
• Device Lot Number: 7021641
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 02/06/2020
• 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: COMMAND GUIDE WIRE; COMMAND GUIDE WIRE