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

Catalog Number UNK ARMADA 18 OTW

Device Problems Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2021

Event Type  Injury  

Manufacturer Narrative

It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.The udi number is not known as the part and lot number were not provided.

Event Description

It was reported that the procedure was to treat a heavily calcified superficial femoral artery.During advancement the unspecified armada 18 balloon dilatation catheter became stuck with the calcification.When attempting to pull back the bdc the shaft separated.The device was removed without the patient suffering any damage; however, it is unknown how the separated portion was removed.Another unspecified device was used to successfully complete the procedure.There was no adverse patient sequela reported and no clinically significant delay reported.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the part and lot numbers were not reported.Based on the information provided, the reported resistance during advancement, difficulty removing, and material separation resulting in unexpected medical intervention to remove the separated segment appears to be due to circumstances of the procedure.It is likely that the difficulty advancing was due to interaction with the heavily calcified lesion in the superficial femoral artery resulting in the distal end of the catheter becoming stuck with the calcification.Additionally, when attempting to pull back the bdc, the shaft separated.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ARMADA 18 PTA CATHETER
• Type of Device: 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: 13401298
• MDR Text Key: 284823855
• Report Number: 2024168-2022-01025
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K151317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK ARMADA 18 OTW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2022
• Initial Date FDA Received: 01/31/2022
• Supplement Dates Manufacturer Received: 02/09/2022
• Supplement Dates FDA Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention