MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Model Number	A2020-200
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 anterior tibial artery with heavy calcification.The 2.0x200mm armada 14 balloon dilatation catheter (bdc) had slight resistance with the anatomy during advancement and was inflated once to a nominal 8 atmospheres (atms) for a three minute inflation.Negative was held for 5 seconds to deflate the balloon.The balloon was fully deflated upon removal.There was resistance with the anatomy during removal and slight force was applied.The balloon got stuck in the anatomy and was left in the patient's leg.The separated balloon was stuck/embedded in the tibial artery.No attempts were made to retrieve the separated portion.At the moment the patient's foot seems to be receiving blood from other vessels and a bypass surgery has been planned in the future.There was a delay in making a decision in the next step in the procedure.The patient was discharged and will return for the bypass surgery.No additional information was provided.
Event or Problem Description
It was reported that the procedure was to treat a lesion in the anterior tibial artery with heavy calcification.The 2.0x200mm armada 14 balloon dilatation catheter (bdc) was inflated to nominal for a three minute inflation.The balloon was deflated, however, there was slight resistance upon attempted removal.The balloon got stuck in the anatomy and was left in the patient's leg.At the moment the patient's foot seems to be receiving blood from other vessels and a bypass surgery has been planned in the future.There was no reported clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was provided.The bdc had slight resistance with the anatomy during advancement and was inflated once to a nominal 8 atmospheres (atms).Negative was held for 5 seconds to deflate the balloon.The balloon was fully deflated upon removal.There was resistance with the anatomy during removal and slight force was applied.The separated balloon was stuck/embedded in the tibial artery.No attempts were made to retrieve the separated portion.There was a delay in making a decision in the next step in the procedure.The patient was discharged and will return for the bypass surgery.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported separation was confirmed.The reported difficulty advancing the device could not be replicated in a testing environment as it was based on operational circumstances.The reported difficulty removing the device 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 of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported difficulty advancing the device, the balloon separation, device embedded in tissue or plaque and delay to treatment/therapy appear to be related to operational context; however, a conclusive cause for the reported difficulty removing the device could not be determined.Possible factors that can contribute to difficult to remove/resistance of the bdc post-inflation include, but are not limited to, patient disease state, pre/post-dilatation strategy, device placement technique, procedural technique, accessory device support, loose balloon folds, guiding catheter lumen obstructions, kinks and bends.In this case, a conclusive cause for the reported difficulty removing the device could not be determined.Furthermore, it is likely that the manipulation of the device and use of slight force during attempts to remove it, as difficulty was encountered, resulted in the balloon ultimately separating.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

• Brand Name: ARMADA 14 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, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16045794
• Report Number: 2024168-2022-13078
• Device Sequence Number: 20399632
• Product Code: DQY
• UDI-Device Identifier: 08717648155994
• UDI-Public: 08717648155994
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K102705
• 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): 02/23/2023

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: 06/30/2025
• Device Model Number: A2020-200
• Device Catalogue Number: A2020-200
• Device Lot Number: 2012441
• 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: 12/06/2022
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 12/24/2022
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2022
• 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: COMMAND 14 GUIDE WIRE.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 96 KG