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

Model Number	B2100-040
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.Na.
Event or Problem Description
It was reported that the procedure was to a lesion in a unspecified artery.The 10mm/40mm armada balloon dilatation catheter (bdc) was advanced to the target lesion; however, the balloon failed to inflate.Therefore, the bdc was removed from the patient.There was no adverse patient effect and no clinically significant delay reported in the procedure.Return device analysis found the balloon was inflated.In addition, the balloon separated 2 centimeters (cm) distal to the distal seal.The proximal portion of the separated balloon was measured to be 3cm long from the proximal seal.The balloon material at the separation was wrinkled and uneven.It appears that portion of separated balloon was not returned with the device.There was a longitudinal balloon rupture that started from its distal end to noted balloon separation.There was a longitudinal balloon rupture that started from its distal end to noted balloon separation.No additional information was provided.
Additional Manufacturer Narrative
Visual and dimensional inspections were performed on the returned device.The reported inflation issue could not be replicated in a testing environment due to the condition of the returned device.The returned device was returned with a longitudinal balloon rupture and the balloon was separated distal to the distal seal.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 inflation issue or the noted balloon rupture and separation.Return analysis noted a longitudinal balloon rupture and the balloon was separated distal to the distal seal.Possible factors that could contribute to balloon material ruptures include, but are not limited to, balloon damage during processing of the balloon material, inflation technique, interactions with other devices or lesion calcification.Additionally, possible factors that may contribute to a balloon separation may include, but not limited to, manufacturing damage, interaction with the anatomy, user attempts to remove against resistance and physician applies excessive force against resistance.In this case, a conclusive cause for the noted balloon rupture and separation cannot be determine since limited information was provided.Furthermore, it is possible that the inflation issue resulted from the noted balloon rupture; however, a conclusive cause cannot be determined since limited information was provided.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• 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: 17087564
• Report Number: 2024168-2023-06043
• Device Sequence Number: 12284138
• Product Code: LIT
• UDI-Device Identifier: 08717648155512
• UDI-Public: 08717648155512
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023

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: 10/31/2025
• Device Model Number: B2100-040
• Device Catalogue Number: B2100-040
• Device Lot Number: 20524G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2022
• 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