MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ARMADA; PERIPHERAL DILATATION CATHETER

Model Number	B1070-060
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat moderately calcified left common iliac artery.The 7.0x60mm armada 35 balloon catheter was advanced with a 7fr sheath; however, resistance was felt during advancement with anatomy.Once at the lesion, the balloon was inflated and ruptured at 4 atmospheres during the first inflation.During removal resistance was felt with anatomy while withdrawing into the sheath and the distal tip separated.The separated tip was removed via snare.An unspecified device was used to successfully complete the procedure.There was no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual analysis was performed on the returned device.The reported balloon rupture and separation were confirmed.The reported difficulty advancing and removing the device could not be replicated in a testing environment as it was based on operational circumstances.The production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed no other similar complaints from this lot.It was reported by the account that the bdc interacted with the moderately calcified anatomy resulting in the reported difficulty advancing and removing of the device in the anatomy.In this case, it is likely that the balloon interacted with the challenging anatomy, resulting in the ruptured during inflation.Additionally, during removal there was resistance as the ruptured balloon material likely interacted with the patient anatomy causing the reported separation.Additional treatment with a snare device was performed to remove the separated portion of the device.The investigation determined the balloon rupture, separation, difficulty advancing and removing the device from the anatomy and unexpected medical intervention appear to be related to operational context.There was no leak noted during preparation, which suggests a product quality issue did not contribute to the reported difficulties.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ARMADA
• Common Device Name: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR INC.; 3200 lakeside drive; santa clara CA 95054 2807
• 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: 20011925
• Report Number: 2024168-2024-09730
• Device Sequence Number: 7230807
• Product Code: LIT
• UDI-Device Identifier: 08717648154799
• UDI-Public: (01)08717648154799(17)260630(10)30120G1
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: B1070-060
• Device Catalogue Number: B1070-060
• Device Lot Number: 30120G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 08/20/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 7FR SHEATH.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 106 KG