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

Model Number A2020-200

Device Problems Difficult or Delayed Positioning (1157); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2022

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat the anterior tibial artery and posterior tibial artery below the knee which was moderately calcified and moderately tortuous the 2.0x200 armada percutaneous transluminal angioplasty (pta) catheter was used once without issue.During the second use, the armada balloon catheter was attempted to be used and the guide wire lumen became curled and would not allow a guide wire to be advanced.The lumen appears kinked and bent inside the catheter.It was also noted that the balloon markers were difficult to see.There was no reported adverse patient effect and there was no reported clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

Visual inspection and flouroscopy were performed on the returned device.The reported kink/bend was confirmed; however, the reported difficult or delayed positioning could not be confirmed.The reported difficulty advancing the guide wire could not be replicated in a testing environment 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 identified no other similar incidents and/or complaints from this lot.The investigation determined the reported kink, difficulty advancing the device and difficult or delayed positioning appear to be related to operational context.It was reported by the account that the armada 14 catheter was successfully used one time in the procedure without any issues.The device was removed and reinserted for additional use.Based on the reported information and the analysis performed on the returned device, it appears that the bdc was inadvertently mishandled during removal after the first successful use of the device.Return analysis noted that the balloon inner member was stretched and folded proximal to the proximal end of the distal marker.The noted stretching likely occurred during removal of the device after first use which resulted in the inner member folding proximal to the proximal end of the distal marker and subsequently resulting in the reported kink, difficulty advancing the device and the markers being difficult to see.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• Brand Name: ARMADA 14 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 13773617
• MDR Text Key: 287675233
• Report Number: 2024168-2022-02673
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08717648155994
• UDI-Public: 08717648155994
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K102705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A2020-200
• Device Catalogue Number: A2020-200
• Device Lot Number: 1080541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1