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

Model Number	B1120-040
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	12/21/2022
Type of Reportable Event	Serious Injury
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 aorta via right femoral access with heavy calcification, mild tortuosity and 40% stenosis.The armada percutaneous transluminal angioplasty (pta) catheter was inflated once to 10 atmospheres when the rupture occurred.The catheter got caught on calcium during removal and could not be removed, so a cutdown surgery was performed.The balloon was successfully removed over the wire after pulling the balloon back into the sheath.The balloon and sheath were removed together.Upon inspection of the device, calcium and biological material were observed lodged in the balloon.The patient was hospitalized additional time but is doing well.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection 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 reported entrapment of device could not be replicated in a testing environment as it was based on operational circumstances.An additional guide wire was returned with the balloon dilatation catheter (bdc).A piece of the guide wire appeared to be cut.The cut portion was not returned.The guide wire appeared to be an abbott guide wire, however, unable to be confirmed due to the device condition.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 determined the reported balloon rupture, entrapment of device, balloon separation, unspecified tissue injury, unexpected medical intervention, surgical intervention, removal of foreign body and hospitalization appear to be related to circumstances of the procedure; however, a conclusive cause for the reported difficulty removing the device from the guide wire could not be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.The returned guide wire is filed under a separate medwatch report.
Event or Problem Description
Subsequent to the initially filed report, the device was received and the distal balloon marker was missing from the armada device.The physician stated he was able to retrieve all of the device from the patient.An unspecified, abbott guide wire was also received and the device was kinked and had been cut and the cut portion was not returned.The account stated that the guide wire was cut intentionally as the balloon catheter was stuck to it and would not come out until the guide wire was cut.No additional information was provided.

• 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: 16125291
• Report Number: 2024168-2023-00302
• Device Sequence Number: 17738027
• Product Code: LIT
• UDI-Device Identifier: 08717648154980
• UDI-Public: 08717648154980
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 03/01/2023

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: 12/31/2024
• Device Model Number: B1120-040
• Device Catalogue Number: B1120-040
• Device Lot Number: 10705G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/21/2022
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 69 KG