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

Model Number	B2080-040
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified, mildly tortuous, de novo lesion in the right common femoral artery.After an unspecified stent was implanted in the right common femoral artery, post-dilatation was being performed with an 8x40mm armada 35 balloon dilatation catheter (bdc), when the balloon ruptured due to the heavy calcification at the lesion.The bdc was then being removed from the anatomy when it became stuck with the tip of the sheath.It was decided that the bdc and sheath would be removed from the lesion as a single unit, however the balloon became stuck in calcium, while the sheath was removed intact.The bdc became separated, and the tip of the device was left inside the vessel.The patient was put under general anesthesia (ga), and a cut down procedure was performed to successfully remove the ruptured balloon from the anatomy.There was no adverse patient sequela, however there was a reported clinically significant delay due to the cut down procedure.No additional information was provided.
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
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.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, difficulty removing the device, balloon separation, entrapment of device, delay to treatment/therapy, surgical intervention, removal of foreign body and hospitalization appear to be related to circumstances of the procedure.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: 14017391
• Report Number: 2024168-2022-03579
• Device Sequence Number: 14592389
• Product Code: LIT
• UDI-Device Identifier: 08717648155437
• UDI-Public: 08717648155437
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 06/13/2022

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: 01/31/2025
• Device Model Number: B2080-040
• Device Catalogue Number: B2080-040
• Device Lot Number: 10819G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• 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
• Patient Age: 75 YR
• Patient Sex: Male