MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number	1013470-150
Medical Device Problem Codes	Failure to Fold (1255); Difficult to Remove (1528); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: medical device problem code 2017 clarifier- contrast incorrect.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 superficial femoral artery (sfa) with heavy calcification.The 6.0x150mm armada balloon dilatation catheter (bdc) was inflated one time to 12 atmospheres and confirmed to be fully deflated before removal.However, during removal the bdc became stuck in the 6fr sheath and a portion of the bdc became separated.As the balloon was still on the guide wire, the entire bdc including the separated portion were removed with the guide wire and the sheath as a single unit.After removal, the balloon was noted to be halfway inside the sheath and bunched.It was further reported that the contrast ration used was 30/70.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.
Event or Problem Description
Additional information: the contrast ratio was 5ml of contrast diluted with 10ml of saline.No additional information was provided.
Additional Manufacturer Narrative
Visual inspection was performed on the returned device.The reported failure to fold (bunched balloon) and separation were confirmed.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 identified no other similar incidents and/or complaints from this lot.It was reported that the contrast mix used in the procedure was 5ml of contrast diluted with 10ml of saline.It should be noted that the percutaneous transluminal angioplasty (pta) catheter, armada 18, ce instructions for use (ifu) specified that the contrast diluted 1:1 with normal saline.In this case, since the contrast ratio used was less than the required percentage it is unknown if the ifu violation caused or contributed to the reported complaint.The investigation was unable to determine a conclusive cause for the reported failure to fold (bunched balloon); however, the reported difficulty removing the device and separation appear to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

• Brand Name: ARMADA 18 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: 17686100
• Report Number: 2024168-2023-09630
• Device Sequence Number: 2609140
• Product Code: LIT
• UDI-Device Identifier: 08717648208447
• UDI-Public: 08717648208447
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K151317
• 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): 11/07/2023

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: 03/31/2026
• Device Catalogue Number: 1013470-150
• Device Lot Number: 2102441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• 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: 6 FR SLENDER SHEATH
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 112 KG