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

Catalog Number UNK ARMADA 35

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

Estimated date of event.The device was not returned for analysis.The reported rupture, and difficult to remove could not be confirmed.The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the part and lot numbers were not reported.The investigation could not determine the cause for the reported rupture and difficult to remove.It may be possible that the balloon was damaged during insertion, or due to interaction with lesion calcification or associated devices causing the balloon to rupture during inflation resulting in difficulty removing from the guide wire; however, this could not be confirmed.The additional treatment was due to case circumstances.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat an iliac artery.An unspecified armada balloon was advanced to the lesion and ruptured at unknown atmospheres.The device was then pinched and pulled off the guide wire, but did not completely come out as the proximal part of the balloon was still on the wire.The sheath was upsized to a 7fr sheath and both devices were able to be pulled out together (balloon stuck on guide wire).There was no adverse patient sequela and no clinically significant delay.No additional information was provided.

• Brand Name: ARMADA 35 OTW
• 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: 11057672
• MDR Text Key: 223205329
• Report Number: 2024168-2020-10845
• 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: Physician
• Type of Report: Initial
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ARMADA 35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: 6FR SHEATH; J-WIRE
• Patient Outcome(s): Required Intervention