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

Model Number	B1060-080
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	10/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device is expected to be returned for investigation.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 lesion in the atrioventricular (av) fistula.A 6x80mm armada 35 percutaneous transluminal balloon dilatation catheter (bdc) was advanced to the target lesion without issue and was inflated the first time, 1 atmosphere above the rated burst pressure (rbp).The second inflation was to 14 atm when the balloon ruptured at the lesion.During withdrawal of the ruptured balloon, resistance was felt between the ruptured balloon and the anatomy, and the balloon separated in the av fistula.The fistula had to be cut open and the ruptured balloon piece removed, ending the procedure.There was a reported delay in the procedure due to the cut down, but no adverse patient sequela and no clinically significant delay in procedure.No additional information was provided.
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.It was reported that the balloon was overinflated the first time, 1 atmosphere above the rated burst pressure (rbp).It should be noted that the percutaneous transluminal angioplasty catheter (pta), armada 35, 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 16 atmospheres as indicated on the product label.It could not be determined if inflating the balloon slightly over the rated burst pressure contributed to the rupture.The investigation was unable to determine a conclusive cause for the reported balloon rupture; however, the reported difficulty removing the device and balloon separation appear to be related to operational context.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.D9, h3: device was not available for evaluation.

• 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: 12707275
• Report Number: 2024168-2021-09676
• Device Sequence Number: 11937952
• Product Code: LIT
• UDI-Device Identifier: 08717648154713
• UDI-Public: 08717648154713
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 11/18/2021

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: 10/31/2024
• Device Model Number: B1060-080
• Device Catalogue Number: B1060-080
• Device Lot Number: 10512G1
• 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: 10/07/2021
• Supplement Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2021
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 172 KG