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

Model Number B1070-080

Device Problems Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/16/2021

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 that supera stents were implanted in the right superficial femoral artery without issue. A 7x80mm armada 35 percutaneous transluminal angioplasty (pta) catheter was then advanced with an unspecified 6f sheath to the heavily calcified, mildly tortuous, 95% stenosed, de novo common femoral artery lesion. The balloon ruptured at nominal pressure. The armada pta catheter felt resistance with the sheath during removal, and the balloon separated in the sheath. The sheath, pta catheter, and an unspecified guide wire were removed together. While advancing another unspecified guide wire and sheath, what appeared to be a piece of the balloon was noted to be caught in the supera stent. A non-abbott balloon was inflated and a covered stent were used to embed the separated portion of balloon against the vessel wall. There were no adverse sequelae and no clinically significant delay in the procedure. 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: 12102059
• MDR Text Key: 259664787
• Report Number: 2024168-2021-05653
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: B1070-080
• Device Catalogue Number: B1070-080
• Device Lot Number: 90622G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2019
• 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: 07/01/2021 Patient Sequence Number: 1