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

Catalog Number 1014253-060

Device Problems Inflation Problem (1310); Stretched (1601)

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

Event Date 01/11/2023

Event Type  malfunction  

Manufacturer Narrative

Visual and functional inspections were performed on the returned device.The reported inflation issue was not confirmed.After leaving the pressurized balloon catheter soaking in warm water bath overnight, the balloon inflated and maintained pressure of 14atm.There was no leak noted.Additionally, it was noted that the shaft was stretched proximal to the proximal seal.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.A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded that there are two images attached to this report, which may show a pre and post image of which looks like the target lesion in the tibial artery.However, the two images are different views/angles of the supposed lesion and does not clearly show the bdc within the lesion, if it is in the vessel at all.Without knowing more details on what equipment/products were used to treat the lesion and without knowing more details on the lesion morphology (calcification, tortuosity, percent stenosis), as well as not knowing if the bdc was prepped per ifu, a conclusion for probable cause of the event cannot be made.The noted stretched shaft was possibly due to manipulation of the device during preparation.The investigation was unable to determine a conclusive cause for the reported inflation issue.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

Event Description

It was reported that the procedure was to treat a lesion in right anterior tibial artery.The 2.50x60mm armada balloon dilatation catheter (bdc) was advanced to the target lesion and attempted to be inflated; however, the balloon failed to inflate.There was no adverse patient effect and no clinically significant delay reported in the procedure.Return device analysis found the shaft of the bdc was stretched.No additional information was provided.

• 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: 16480977
• MDR Text Key: 310675056
• Report Number: 2024168-2023-02196
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K151317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1014253-060
• Device Lot Number: 2071941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2022
• 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 Age: 38 YR
• Patient Sex: Male