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

Model Number B2060-200

Device Problems Inflation Problem (1310); Leak/Splash (1354); Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2022

Event Type  malfunction  

Manufacturer Narrative

The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that the procedure was to treat an occluded, mildly calcified, mildly tortuous, de novo lesion in the superficial femoral artery (sfa).A non-abbott guide wire passed the lesion without reported issue and the 6.0x200 mm armada 35 percutaneous transluminal angioplasty (pta) catheter was inflated; however it is unknown to what pressure or how many times.Leakage was noted from the catheter and the balloon did not inflate at all so the armada 35 was removed.A non-abbott balloon was used to complete the procedure.There were no reported adverse patient effects and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

Visual and functional inspections were performed on the returned device.The reported inflation issue and leak could not be confirmed.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 similar incidents and/or complaints from this lot.The investigation was unable to determine a conclusive cause for the reported leak or inflation issue.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.H6: medical device problem code 1546 removed.

Event Description

Subsequent to the initially filed report, the following information was provided: the connection between the balloon and shaft was leaking.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: 14595075
• MDR Text Key: 293354358
• Report Number: 2024168-2022-05948
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 08717648155321
• UDI-Public: 08717648155321
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B2060-200
• Device Catalogue Number: B2060-200
• Device Lot Number: 10129G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2021
• 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: GUIDEWIRE (V-18)