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

Model Number	B1080-060
Medical Device Problem Codes	Off-Label Use (1494); 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	06/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: medical device problem code 2017 - above rbp h6: medical device problem code 1494 - incorrect anatomy.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the left cephalic arch vein with mild tortuosity.The 8/60mm armada 35 percutaneous transluminal angioplasty (pta) catheter was advanced to the lesion and inflated once, but the balloon ruptured when inflated to 23 atmospheres.The balloon separated and one part remained on the balloon catheter and the other part was on the guide wire.Nothing was left in the anatomy.After the armada was removed, the proximal marker was noted to be missing but was found on the table.Another 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.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported balloon rupture and separations were confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.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 inflated to 23 atmospheres and ruptured.It should be noted that the armada 35 / armada 35 ll 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 that overinflating the balloon resulted in the reported balloon rupture.Furthermore, it is likely that the balloon did not refold properly, as a result of the balloon rupture, and subsequently resulted in the reported separations during removal.Additionally, it was reported that the procedure was to treat a lesion in the left cephalic arch vein.It should be noted that the ifu states: the device is intended for dilatation of lesions in the renal, iliac, femoral, popliteal, tibial, and peroneal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.This device is also indicated for stent post-dilatation in the peripheral vasculature.In this case, it is unknown if the ifu violation caused or contributed to the reported complaint.The investigation determined the reported balloon rupture appears to be related to user error; however, the reported separations appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
Event or Problem Description
Subsequent to the previously filed report, returned device analysis identified that one of the balloon marker was not returned.The account stated the marker was removed from the patient's body and was discarded.No additional information was provided.
Additional Manufacturer Narrative
Nah6 - medical device problem code1494 was removed.

• 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: 17362520
• Report Number: 2024168-2023-07772
• Device Sequence Number: 6068778
• Product Code: LIT
• UDI-Device Identifier: 08717648154874
• UDI-Public: 08717648154874
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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,Followup
• Report Date (Section B): 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: B1080-060
• Device Catalogue Number: B1080-060
• Device Lot Number: 30216G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 08/03/2023; 09/07/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/22/2023; 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2023
• 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
• Patient Age: 55 YR
• Patient Sex: Male