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

Model Number	B2070-100
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.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 appears to be related to user error; however, the reported difficulty removing the device, balloon separation, removal of foreign body and unexpected medical intervention appear to be related to circumstances of the procedure.It was reported by the account that the armada 35 balloon dilatation catheter (bdc) was overinflated to 21 atmospheres (atm) and the balloon ruptured.It should be noted that the percutaneous transluminal angioplasty catheter (pta), armada 35/ armada 35ll global, ce, instruction for use (ifu) states: ¿inflation in excess of the rated burst pressure may cause the balloon to rupture.Use of a pressure monitoring device is recommended.¿ the rated burst pressure for this device is 14 atmospheres as indicated on the product label.In this case, it is likely the ifu deviation of overinflating the balloon resulted in the reported balloon rupture.In addition, the difficulty reported during removal and separation of the balloon were likely the result of the ruptured balloon material catching on the introducer sheath during removal.Additional treatment with a snare device was performed to retrieve the separation balloon material.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.(b)(4).
Event or Problem Description
It was reported that the procedure was performed in the subclavian to treat a lesion in the atrioventricular fistula (av).The fistula was used for hemodialysis.The lesion was predilated with the 7mm/100mm armada 35 percutaneous transluminal angioplasty (pta) catheter.The device was advanced without resistance and then inflated once passing the rated burst pressure and a rupture occurred at 21 atmospheres.When the device was being pulled out of the sheath met resistance and the balloon material sheared off.A snared device was used to retrieved the separation balloon material.The same armada was used to complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.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: 16325490
• Report Number: 2024168-2023-01286
• Device Sequence Number: 18346335
• Product Code: LIT
• UDI-Device Identifier: 08717648155383
• UDI-Public: 08717648155383
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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
• Report Date (Section B): 02/08/2023

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: 07/31/2025
• Device Model Number: B2070-100
• Device Catalogue Number: B2070-100
• Device Lot Number: 20216G2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• 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 Age: 71 YR
• Patient Sex: Female
• Patient Weight: 77 KG