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

Model Number	B2040-150
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the superficial femoral artery with mild calcification and mild tortuosity.The 4.00x150mm armada balloon dilatation catheter(bdc) was attempted to be inflated, but the balloon was only able to partially inflate and a contrast leak was noted near the shaft of the balloon catheter.Negative pressure was applied and the bdc was removed form the patient.There was no adverse patient effect and no clinically significant delay in the procedure.The bdc was noted to be prepped (air aspiration) prior to use.Another same size balloon was used in the procedure without issue.No additional information was provided.
Additional Manufacturer Narrative
Visual, functional and scanning electron microscopy (sem) analysis was performed on the returned device.The reported inflation issue and leak were confirmed.Analysis of the returned product indicated the balloon dilatation catheter (bdc)was returned with blood visible inside the sidearm, in between the loosely folded balloon folds and with contrast visible inside the balloon, consistent with preparation and advancement in the anatomy.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 sem report determined the device failure may be attributed to leakage at the sidearm.No evidence of mechanical damage was observed in the dual lumen shaft at the inflation port.The positioning of the lumen at the distal adhesive area and slight gap detected in one region suggests that a potential source of leakage may possibly be related to adhesive bonding.The investigation has determined that the reported inflation issue and leak is not related to a potential product quality issue as the occurrence rate is within the acceptable range of the risk assessment.

• Brand Name: ARMADA 35 PTA CATHETER
• Common Device Name: 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: 15009362
• Report Number: 2024168-2022-07673
• Device Sequence Number: 14032583
• Product Code: LIT
• UDI-Device Identifier: 08717648155130
• UDI-Public: 08717648155130
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K111899
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: B2040-150
• Device Catalogue Number: B2040-150
• Device Lot Number: 10608G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown