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

Model Number B1070-080

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2020

Event Type  Injury  

Manufacturer Narrative

The product was not returned to abbott vascular for analysis.A review of the electronic lot history record (elhr) and similar incident query for this product were not performed since the lot number was not reported.There was no damage noted to the balloon catheter during the inspection prior to use which suggests a product quality issue with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported difficulty to remove the balloon catheter resulting in a balloon separation appears to be related to operational circumstances of the procedure.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 a right arteriovenous fistula graft lesion.A 7x80mm armada 35 balloon was advanced and inflated and deflated without issue.During removal, resistance was met with the guide catheter and the balloon became detached from the catheter.The separated balloon was removed via intervention with a hemostat.There was no adverse patient sequela or clinically significant delay.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: 10150499
• MDR Text Key: 195024464
• Report Number: 2024168-2020-04982
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648154805
• UDI-Public: 08717648154805
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B1070-080
• Device Catalogue Number: B1070-080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 127