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.

Manufacturer Narrative

Visual analysis was performed on the returned device.The reported balloon rupture and separation were confirmed.The difficulty removing was not tested due to the condition of the 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 indication of a lot specific product quality issue.The investigation determined that the reported difficulties were due to case related circumstances.It is likely that the balloon rupture occurred due to interaction with the previously implanted stent as it was reported that angiography noted the balloon marker was caught on the stent.In addition, the resistance noted during removal and separation of the balloon and inner member were likely the result of the ruptured balloon material catching on the previously implanted stent and guide wire resulting in difficulty removing and separation.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ARMADA 35 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10172131
• MDR Text Key: 195705918
• Report Number: 2024168-2020-05168
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648154980
• UDI-Public: 08717648154980
• Combination Product (y/n): N
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• 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: Health Professional
• Device Expiration Date: 07/31/2023
• 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
• Date Manufacturer Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Weight: 75