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

Catalog Number UNK ARMADA 35

Device Problems Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/12/2021

Event Type  Injury  

Event 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.

Manufacturer Narrative

Date of event: 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 is being filed under a separate medwatch report number.The udi is unknown due to the part/lot number were not provided.

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 part and lot numbers were 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.The udi is unknown because the part and lot numbers were not provided.

• Brand Name: ARMADA 35 PTA CATHETER
• Type of Device: 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: 13177698
• MDR Text Key: 283321462
• Report Number: 2024168-2022-00173
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K111899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: UNK ARMADA 35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2021
• Initial Date FDA Received: 01/06/2022
• Supplement Dates Manufacturer Received: 01/13/2022
• Supplement Dates FDA Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 10X60MM ARMADA 35
• Patient Outcome(s): Required Intervention