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

Model Number	B2070-040
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2022
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 was unable to determine a conclusive cause for the reported balloon rupture; however, the reported difficulty removing the device, balloon separation, unexpected medical intervention and removal of foreign body 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
It was reported that the procedure was performed to treat a lesion in the left iliac artery.The armada 35 was advanced to the lesion and inflated but ruptured at an unknown pressure.Difficulty was noted during removal, as the balloon accordioned on the shaft.The balloon portion separated and was able to be snared.All portions of the device were removed from the patient anatomy.No additional information was provided.
Additional Manufacturer Narrative
The investigation was unable to determine a conclusive cause for the reported balloon rupture; however, the reported difficulty removing the device, balloon separation, unexpected medical intervention, removal of foreign body and surgical intervention appear to be related to circumstances of the procedure.A conclusive cause for the reported patient effect of hemorrhage 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.Attachment: user facility medwatch report form (mw5108874).H6: health effect - clinical code 4582 - removed.
Event or Problem Description
Subsequent to the initial report, a user facility medwatch report form (mw5108874).Description: "a 7 x 40 balloon was placed into right iliac artery to open up stenosis, and when the balloon was inflated it ruptured.The surgeon then had to make a larger opening to be able to remove the remains of the balloon.They were unable to use a closure device due to the size of the opening.They then held pressure for 20 mins then placed a dressing on the access site and took the patient to recovery.Once in recovery the patient began to bleed more and was taken back to the operating room.They were able to hold pressure for additional time to get the bleeding to stop and did not have to do a cut down.The patient was then taken back to recovery.Fda safety report id# (b)(4).".

• 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: 14047158
• Report Number: 2024168-2022-03714
• Device Sequence Number: 4907721
• Product Code: LIT
• UDI-Device Identifier: 08717648155352
• UDI-Public: 08717648155352
• 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,Followup
• Report Date (Section B): 05/31/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: B2070-040
• Device Catalogue Number: B2070-040
• Device Lot Number: 11206G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2022
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 05/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2021
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 78 KG