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

Model Number B1120-040

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

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 06/05/2020

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 the procedure was performed to treat a lesion in a previously created right radiocephalic arteriovenous (av) fistula. The patient has a history of stenosis of the subclavian/innominate vein, causing arm swelling, with implantation of an unspecified stent to treat the stenosis. The patient presented with swelling in her right arm and the procedure was performed to treat stenosis of the av fistula. The 12. 0 x 40 mm armada 35 dilatation catheter was advanced to the target site. The balloon was inflated to 5 atmospheres (atm) and the balloon ruptured. An attempt was made to remove the dilatation catheter; however, resistance was noted and it was obvious that something was preventing the removal of the device. The dilatation catheter was able to come out of the sheath, but it could not be removed from the guide wire. It appeared that the tip of the catheter and balloon may have separated and remained in the anatomy. Angiography noted that the balloon marker was caught on the previously implanted stent. The dilatation catheter was cut and removed from the guide wire. A 6 french non-abbott sheath was then advanced over the guide wire and the guide wire was removed. It appeared that the ruptured balloon had wrapped around the guide wire, causing the difficult removal. Angiography noted the distal radiopaque balloon marker in the subclavian vein. The decision was made to implant a covered stent to cover the entire area. Additional post dilatation was performed and final angiography noted that the stent was widely patent. 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: 10172131
• MDR Text Key: 195705918
• Report Number: 2024168-2020-05168
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: B1120-040
• Device Catalogue Number: B1120-040
• Device Lot Number: 00203G2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2020
• 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: 06/18/2020 Patient Sequence Number: 1