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

Model Number	B1070-060
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	09/05/2022
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that the procedure was to treat a de novo lesion in the mid left iliac artery with 80% stenosis, heavy calcification and mild tortuosity.The 7.0x60mm armada 35 balloon dilatation catheter (bdc) had no resistance during advancement, however, burst during the first inflation at 4 atmospheres (atms) in a circular form.The armada 35 bdc was soaked and prepared (air aspiration) outside the anatomy prior to use.There was resistance during removal when trying to withdraw the delivery system of the balloon as a unit.Upon removal, the balloon and delivery catheter were noted to be separated and surgical arteriotomy was performed to remove the proximal part of the balloon and delivery catheter.There was no adverse patient sequela.There was a delay of 1 hour in the procedure due to the surgery.No additional information was provided.
Additional Manufacturer Narrative
A visual and scanning electron microscopy (sem) inspection/analysis were 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.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 and separation appear to be related to circumstances of the procedure.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.Based on the reported information and analysis of the returned device, it is likely that the balloon rupture was the result of interaction with the heavily calcified lesion.Additionally, during removal there was resistance as the balloon interacted with the sheath causing the balloon and inner member material to separate.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: 15473203
• Report Number: 2024168-2022-09965
• Device Sequence Number: 2873466
• Product Code: LIT
• UDI-Device Identifier: 08717648154799
• UDI-Public: 08717648154799
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 11/07/2022

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: 06/30/2025
• Device Model Number: B1070-060
• Device Catalogue Number: B1070-060
• Device Lot Number: 20126G1
• 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: 09/06/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2022
• 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 Sex: Unknown