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

Catalog Number	B1080-040
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Swelling/ Edema (4577)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: medical device problem code 2017 - excessive force.Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the common femoral artery (cfa) with 91% stenosis, heavy calcification and no tortuosity.The 8.0x40mm armada 35 balloon dilatation catheter (bdc) was advanced with slight resistance with the anatomy and ruptured during the first inflation at 6 atmospheres (atms).Upon removal, the balloon got stuck on the guide wire and excessive force was applied removing the guide wire and bdc as a single unit.Enlargement of the access site and hemorrhage were noted and was treated by manual compression.Hemostasis was obtained after 15 minutes and there was a delay in the procedure of 30 minutes.The patient is under observation and will have another operation in order to treat the initial lesion.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported balloon rupture was confirmed.The reported difficulty to advance could not be replicated in a testing environment as it was based on operational circumstances.The reported difficulty to remove could not be replicated in a testing environment due to the condition of the returned device.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 reported patient effect of hemorrhage/blood loss/bleeding is listed in the percutaneous transluminal angioplasty (pta) catheter, armada 35 / armada 35 ll, global, instruction for use as a known patient effect.It was reported by the account that the excessive force was applied to remove the device.It should be noted that the percutaneous transluminal angioplasty catheter (pta), armada 35/ armada 35ll global, ce, instruction for use states: maintaining a vacuum in the balloon, withdraw the catheter.Note: gentle counterclockwise twisting motion of the balloon may ease withdrawal through the sheath or from the percutaneous entry site.If the balloon cannot be withdrawn through the sheath, withdraw the catheter and sheath as one unit.In this case, the physician did not follow the instructions for use.Instead of using gentle counterclockwise twisting motion to remove the device, force was applied.Returned device analysis noted that the balloon and inner member were returned separated.In this case, it is likely that the noted separation resulted from handling of the device with excessive force during removal.The investigation determined the reported difficulty advancing the device, balloon rupture, delay to treatment/therapy and unexpected medical intervention appear to be related to operational context; however, a conclusive cause for the reported difficulty removing the device could not be determined.A conclusive cause for the reported patient effects of hemorrhage/blood loss/bleeding and swelling/edema and the relationship to the device, if any, cannot be determined.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: 18078667
• Report Number: 2024168-2023-12300
• Device Sequence Number: 6789123
• Product Code: LIT
• UDI-Device Identifier: 08717648154867
• UDI-Public: 08717648154867
• 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): 01/09/2024

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: 07/31/2026
• Device Catalogue Number: B1080-040
• Device Lot Number: 30202G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 0.035 GUIDE WIRE; 6FR SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown