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

Model Number	B1100-080
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Stretched (1601)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/24/2024
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 an arteriovenous fistula with 80-90% stenosis.The 10x80 mm armada percutaneous transluminal angioplasty (pta) catheter was inflated four times to nominal pressure in a stenosed non-abbott stent and ruptured on the fourth inflation.The balloon was deflated, and negative pressure was held for more than 20 seconds, but there was difficulty removing the balloon.The balloon was removed from the patient with the shaft stretched.The balloon was noted to be burst and distorted and the markers were seen to have remained in the patient in the right atrium.Snaring was attempted but was unsuccessful.A non-abbott high pressure balloon was inflated to complete the procedure, and the patient was then discharged.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported balloon rupture, stretched shaft, and separation were confirmed.The reported difficulty to remove could not be replicated in a testing environment as it was based on operational circumstances.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other similar complaints from this lot.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported balloon rupture, stretched shaft, difficulty removing the device, separation, foreign body in patient and unexpected medical intervention appear to be related to circumstances of the procedure.There was no leak noted during preparation or during the initial three inflations, which suggests a product quality issue did not contribute to the reported difficulties.In this case, it is likely that the balloon interacted with the patient¿s anatomy and/or previously implanted stent such that the balloon became damages and ruptured during the fourth inflation.The resistance reported during removal likely result from the ruptured balloon material catching on the patient¿s anatomy and/or previously implanted stent during removal as the rupture likely did not allow the balloon material to refold properly.Return device analysis noted the material at the separation was jagged which suggests that the separation may be related to tensile overload (material stress/fatigue).It is likely that upon manipulation of the device during removal, as difficulty was encountered, the shaft likely became stretched and ultimately separated.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: 20472504
• Report Number: 2024168-2024-12238
• Device Sequence Number: 7472241
• Product Code: LIT
• UDI-Device Identifier: 08717648154966
• UDI-Public: (01)08717648154966(17)270131(10)30807G1
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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): 11/14/2024

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: B1100-080
• Device Catalogue Number: B1100-080
• Device Lot Number: 30807G1
• 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: 09/26/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2023
• 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: COVERA STENT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female