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

Catalog Number	B2120-060
Medical Device Problem Codes	Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 12x60mm armada 35 balloon dilatation catheter (bdc) yellow protective sheath could not be removed from the device.Another unspecified balloon was used to complete the procedure.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
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 complaint from this lot.The investigation was unable to determine a conclusive cause for the reported complaint.Possible factors that may contribute to difficulty removing the protective sheath may include, but not limited to, manufacturing, normal variation within the manufacturing process or protective sheath removal technique.A conclusive cause for the reported complaint could not be determined since the device and component were not returned for analysis.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.D9 - device available for evaluation updated from ¿yes¿ to ¿no¿.
Additional Manufacturer Narrative
Visual and functional inspection was performed on the returned device.The reported complaint was confirmed.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 complaint from this lot.The investigation was unable to determine a conclusive cause for the reported difficulty removing the protective sheath.Possible factors that may contribute to difficulty removing the protective sheath may include, but not limited to, manufacturing, incorrect preparation, normal variation within the manufacturing process or protective sheath removal technique.Additionally, it was reported that the device was prepped with the protective sheath on.It should be noted that the percutaneous transluminal angioplasty (pta), armada 35 / armada 35 ll, instructions for use (ifu) states: perform the following steps to remove all air and verify the integrity of the pta catheter.Step 1 being fill an inflation device/syringe with a mixture of contrast medium and normal saline.Step 2, remove protective tubing from the balloon and continuing with the following steps to expel all air while maintain the catheter under negative pressure.In this case, it is possible that prepping the device with the protective sheath on could contribute to the reported difficulty removing the protective sheath; however, a conclusive cause cannot be determined.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of this device.D9: device available for evaluation changed to yes.H6: type of investigation code 4114 removed.H6: investigation findings code 3221 removed.
Event or Problem Description
Subsequently, after the initial was filed it was noted that the device was prepped with the sheath on.No additional information was provided.

• 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: 17586091
• Report Number: 2024168-2023-09049
• Device Sequence Number: 11962458
• Product Code: LIT
• UDI-Device Identifier: 08717648155567
• UDI-Public: 08717648155567
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Followup
• Report Date (Section B): 02/28/2024

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: 06/30/2025
• Device Catalogue Number: B2120-060
• Device Lot Number: 20118G1
• 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: 07/31/2023
• Supplement Date Received by Manufacturer: 10/31/2023; 02/13/2024
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 11/03/2023; 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2022
• 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
• Patient Sex: Unknown