MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	A2025-060
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2018
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.Evaluation summary: visual and dimensional inspections were performed on the returned device.The outer member was bunched and torn.The resistance with the guide wire was unable to be confirmed due to the condition of the returned device.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 of the reported lot revealed no other incidents.The reported difficulties appear to be due to case circumstances.It is likely that during use the clearance between the inner member of the catheter and the guide wire became reduced causing the catheter to become frozen over the guide wire.Continued attempts to remove the catheter likely caused the noted shaft damage.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 performed to treat a lesion in the lower extremity.Resistance between a 2.5mm x 60mm x 150 cm armada 14 percutaneous transluminal angioplasty (pta) balloon catheter and an asahi gladius guidewire was felt.The guidewire became stuck in the balloon catheter and was unable to be removed.The balloon catheter and guidewire were removed from the patient anatomy together as a single unit.The procedure was successfully completed with an additional armada 14 balloon catheter and a command guidewire.There were no adverse patient effects.There was a reported delay in procedure; however, there were no adverse patient effects.No additional information was provided.

• Brand Name: ARMADA 14 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: 7785317
• Report Number: 2024168-2018-06264
• Device Sequence Number: 14007801
• Product Code: LIT
• UDI-Device Identifier: 08717648156021
• UDI-Public: 08717648156021
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K102705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/15/2018

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: 09/30/2021
• Device Catalogue Number: A2025-060
• Device Lot Number: 8041241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1