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

Model Number	B2100-060
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event has been estimated.The customer reported the device is not returning.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional device referenced in is being filed under a separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat a heavily calcified re-thrombosed stent.After the 10x60mm armada 35 balloon dilatation catheter (bdc) was advanced to the lesion, and after several inflations of the balloon, between nominal pressure and above nominal, the balloon ruptured.It was noted the rupture occurred due to the previously implanted stent had fractured and caused the balloon to rupture on contact.During removal of the bdc resistance was met with the introducer and the central sheath of the balloon separated.It was noted another unspecified armada 35 bdc was advanced; however, the same exact issue occurred and bdc ruptured at an unknown pressure.Therefore, two fragments remained in the anatomy and the fragments were pressed against the vascular wall.There was no adverse patient sequela reported and no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided.The investigation determined the reported balloon rupture, difficulty removing the device, balloon separation, additional treatment and device embedded in the tissue or plaque appear to be related to circumstances of the procedure.It was reported by the account that the balloon interacted with the previously implanted fractured stent resulting in the reported balloon rupture.In addition, the resistance noted during removal and separation of the balloon material was likely the result of the ruptured balloon material catching on the introducer sheath during removal.Additional treatment was performed to press the separated fragments against the vascular wall.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: 13177583
• Report Number: 2024168-2022-00170
• Device Sequence Number: 4624677
• Product Code: LIT
• UDI-Device Identifier: 08717648155529
• UDI-Public: 08717648155529
• 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): 02/03/2022

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 Model Number: B2100-060
• Device Catalogue Number: B2100-060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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