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

Model Number	B1070-080
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a target lesion in the severely stenosed left brachial vein.The 7.0 x 80 mm armada 35 dilatation catheter was advanced to the target lesion.The balloon was inflated without issue; however, it could not be deflated.The physician connected two different indeflators, but was unable to deflate the balloon.A 20 cc syringe was then attached, but the balloon could still not be deflated.The physician then administered 3000 units of heparin and administered lidocaine at the region.An 18 gauge needle was then used, through the skin, to puncture the balloon.The balloon was then able to deflate and was removed.A second armada dilatation catheter was then used to complete the dilatation.There was no adverse patient sequela and the patient was doing well post procedure.There was no clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
Visual, dimensional, and functional inspections were performed on the returned balloon dilatation catheter (bdc).The reported deflation issue was unable to be confirmed due to the puncture on the balloon.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 incidents and/or complaints reported from this lot.Possible factors that may contribute to deflation failure or slow deflation of the device may include, but not limited to, manufacturing damage, deflation technique, anatomical conditions/patient anatomical morphology, contrast mixing/dilution, bends, or kinks of the shaft while inside the anatomy affecting the inflation/deflation lumen and/or stretched outer member thereby reducing the deflation lumen or constricting contrast flow.The investigation was unable to determine a conclusive cause for the reported deflation issue.In this case it is possible that the challenging anatomical conditions restricted contrast flow resulting in the reported failure to deflate; however, this could not be confirmed.Additionally, the treatment appears to be related to the operational context of the procedure as the physician administered heparin, lidocaine and an 18-gauge needle was used through the skin, to puncture the balloon.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• 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: 12829917
• Report Number: 2024168-2021-10486
• Device Sequence Number: 16504258
• Product Code: LIT
• UDI-Device Identifier: 08717648154805
• UDI-Public: 08717648154805
• 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
• Report Date (Section B): 12/21/2021

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: 12/31/2024
• Device Model Number: B1070-080
• Device Catalogue Number: B1070-080
• Device Lot Number: 10719G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2021
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 63 KG