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

Model Number A2040-080

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

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

Event Date 05/31/2023

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a mildly calcified, mildly tortuous lesion in the common femoral artery (cfa).An ht command 14 guide wire (gw) was advanced to the lesion without resistance, and a 4.0mmx80mmx150cm armada 14 balloon dilatation catheter (bdc) was advanced over the gw without resistance and inflated without issue.During an attempt to deflate the armada balloon, deflation was difficult, negative was held for approximately 30 seconds and the balloon only partially deflated after multiple attempts.An attempt was made to remove the bdc from the anatomy, however the bdc became stuck on the command gw and both devices had to be removed as a single unit.A new guide wire and balloon dilatation catheter were used to successfully complete the procedure.There were no reported adverse patient effects and no clinically significant delays in the procedure.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The additional ht command 14 device referenced in b5 are filed under separate medwatch report number.

Manufacturer Narrative

Visual inspection was performed on the returned device.The reported difficulty removing the device was confirmed.The reported deflation problem could not be replicated in a testing environment due to the condition of the returned device.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 and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported deflation issue; however, the reported difficulty removing the device appears to be related to operational context.There is no indication of a product quality issue with respects to the 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: 17186568
• MDR Text Key: 318194259
• Report Number: 2024168-2023-06632
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08717648156151
• UDI-Public: 08717648156151
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/31/2023

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
• Device Operator: Health Professional
• Device Model Number: A2040-080
• Device Catalogue Number: A2040-080
• Device Lot Number: 2081141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: 07/17/2023
• Supplement Dates FDA Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2022
• 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
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 56 KG