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

Model Number	B1050-100
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2024
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 recanalization procedure was to treat a lesion in the superficial femoral artery (sfa) with stenosis and moderate to heavy calcification.The 5.0x100mm armada 35 balloon dilatation catheter (bdc) was advanced without resistance and inflated once at 8 atmospheres (atms).The balloon ruptured due to possible contact with the calcification and got stuck in the 6french (f) introducer upon removal.No force was applied.The balloon separated and a portion remained in the anatomy.A right femoropopliteal bypass under anesthesia was performed to remove the separated portion of the balloon which caused a delay.Nothing remains in the anatomy.There was no adverse patient sequelae.There was additional hospitalization for the patient.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 removing the device could not be replicated in a testing environment due to the condition of the returned device.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.The investigation determined the reported balloon rupture, difficulty removing the device, balloon separation, delay to treatment/therapy, surgical intervention and hospitalization appear to be related to operational context.Balloon material ruptures can be affected by numerous factors including, but not limited to, balloon damage during processing of the balloon material, materials, inflation technique, and interactions with other devices or lesion calcification.In this case, it is likely that the balloon interacted with the moderately to heavily calcified anatomy such that the balloon became damaged and ruptured during inflation.Additionally, during removal there was resistance with the introducer sheath as the ruptured balloon material likely interacted with the sheath causing the balloon material to separate.Surgery was performed to remove the separated portion of the device resulting in a delay in the treatment and hospitalization.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Event or Problem Description
It was reported that the recanalization procedure was to treat a lesion in the superficial femoral artery (sfa) with stenosis and calcification.The 5.0x100mm armada 35 balloon dilatation catheter (bdc) was advanced without resistance and inflated once at 8 atmospheres (atms).The balloon was deflated; however, got stuck in the 6french (f) introducer and could not be removed.No force was applied.The balloon separated and a portion remained in the anatomy.A right femoropopliteal bypass under anesthesia was performed to remove the separated portion of the balloon which caused a delay.Nothing remains in the anatomy.There was no adverse patient sequelae.There was additional hospitalization for the patient.Subsequent to the initially filed report, the following information was provided: calcification was moderate to heavy.No additional information was provided.

• 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: 19440541
• Report Number: 2024168-2024-06469
• Device Sequence Number: 8578351
• Product Code: LIT
• UDI-Device Identifier: 08717648154638
• UDI-Public: (01)08717648154638(17)270331(10)31020G1
• 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): 07/12/2024

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 Model Number: B1050-100
• Device Catalogue Number: B1050-100
• Device Lot Number: 31020G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 05/31/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• 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: 6F INTRODUCER SHEATH.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown