MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER

Model Number B1060-080

Device Problems Difficult to Remove (1528); Material Rupture (1546); Stretched (1601)

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

Event Date 09/10/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported this was a procedure to treat heavily calcified ne novo lesion of the left popliteal artery. An armada 35 6x80 mm was inserted and inflated to 12atm. The device functioned as intended, so the physician moved the balloon proximal and inflated again with 12atm. However, this time, the balloon burst. The physician then attempted to pull the balloon into the 6f catheter but was unable to do so. Angiography showed the balloon had become stretched and had curled up. The physician then pulled all the devices back towards the puncture site. While removing the devices out of the patient through the common femoral artery, the balloon became stuck on the catheter and also became stuck in the puncture site. For removal, a surgeon had to surgically open the common femoral artery resulting in a clinically significant delay in the procedure. The device was successfully removed, and no additional treatment was performed. No additional information was provided.

• Brand Name: ARMADA 35 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 COSTA RICA, REG # 3009564766; 52 calle 3 b31 coyol free zone; el coyol alajuela ; CS
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 12647653
• MDR Text Key: 276882656
• Report Number: 2024168-2021-09301
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: B1060-080
• Device Catalogue Number: B1060-080
• Device Lot Number: 10311G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/18/2021 Patient Sequence Number: 1

Treatment

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