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

Model Number	B2060-120
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a lesion in an unspecified artery.The 6.0x120mm armada 35 balloon dilatation catheter (bdc) was used, however, there was resistance during withdrawal of the balloon over the introducer.It was noted that the delivery catheter was stretched and trapped the wire inside it.The balloon was inflated twice under nominal pressure and negative was held around 3-5 seconds.There was no deflation issue reported and the balloon was withdrawn completely deflated.There was no difficulty removing the stylet or protective sheath.The device was not prepared (air aspiration) outside the anatomy prior to use.The contrast mix was 40% contrast and 60% heparin fluid.Under active aspiration, all devices were removed as a single unit.Another armada 35 was used to complete the procedure.A second device was stretched in the same way but it was during manipulation at the back table and it was after it was successfully used and removed from the patient.The second device had no issues and the physician performed a catheter stress tension test on the table after use with the same result.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
(b)(6) 2022 (b)(4).The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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 of the reported lot did not indicate a lot specific quality issue.It was reported that the contrast mix used during the procedure was 40% contrast and 60% heparin fluid.It should be noted that the armada 35 / armada 35 ll instruction for use (ifu) specified that the contrast is 60% contrast diluted 1:1 with normal saline.In this case, 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 difficulty removing the device from the introducer sheath; however, the reported stretched shaft appears to be related to circumstances of the procedure.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.H6- medical device problem code 2017 "incorrect prep" removed.

• 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: 16034568
• Report Number: 2024168-2022-13012
• Device Sequence Number: 20639179
• Product Code: LIT
• UDI-Device Identifier: 08717648155307
• UDI-Public: 08717648155307
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Report Date (Section B): 02/15/2023

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: 08/31/2025
• Device Model Number: B2060-120
• Device Catalogue Number: B2060-120
• Device Lot Number: 20325G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2022
• 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 Age: 81 YR
• Patient Sex: Male
• Patient Weight: 75 KG