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

Model Number B1070-040

Device Problems Material Rupture (1546); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/09/2020

Event Type  Injury  

Manufacturer Narrative

The product was not returned to abbott vascular for analysis.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 other incidents and/or complaints reported from this lot.Based on the limited information provided, the investigation was unable to determine a conclusive cause for the reported balloon rupture and marker separation.It is possible that during advancement the balloon became compromised and/or damaged against the anatomy or other devices used in the procedure resulting in radial balloon rupture.Due to the balloon rupture, the balloon was unable to refold and possibly causing resistance with the guiding catheter ultimately resulting in an inner member, balloon marker and balloon separation; however, this could not be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that during a fistulaplasty, the armada balloon ruptured on the first inflation at 15 atmospheres.The distal marker became detached and was left in the anatomy without intervention.There was no adverse patient sequela or a clinically significant delay in procedure.Another balloon was used to finish 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: 10422847
• MDR Text Key: 203454927
• Report Number: 2024168-2020-06887
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648154782
• UDI-Public: 08717648154782
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: B1070-040
• Device Catalogue Number: B1070-040
• Device Lot Number: 00313G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2020
• 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): Other
• Patient Age: 53 YR