MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

Catalog Number 1014254-100

Device Problems Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/25/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: visual inspection was performed on the returned device.The reported balloon rupture and separation was confirmed.The resistance and difficulty removing was not tested as it was related to case circumstances.The investigation determined that the reported difficulties and subsequent treatments were due to case circumstances.It is likely that the reported resistance and balloon rupture were due to interaction with the anatomy causing damage to the outer surface of the balloon.The difficulty removing and separation likely occurred due to the ruptured balloon material becoming entrapped within the significant angulation of the arteriovenous fistula during removal.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 incidents from this lot.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was performed to treat stenosis at an arteriovenous fistula on an anastomosis with a significant angulation.The 3.0x100mm armada 18 otw percutaneous transluminal angioplasty catheter was advanced to the lesion with resistance with the anatomy, and the balloon ruptured during the first inflation at 4 bar.There was resistance noted with the anatomy during withdrawal, and force was applied.The balloon separated in two pieces during withdrawal from the arteriovenous fistula, and the balloon remained on the guide wire.A small incision was made around the introducer, and small forceps were used to extract the balloon from the patient anatomy, which extended the procedure time.The procedure concluded after the balloon was retrieved.There was no adverse patient sequela and no reported clinically significant delay in the procedure.No additional information was provided.

• Brand Name: ARMADA 18 PTA CATHETER
• Type of Device: PERIPHERAL DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 8001571
• MDR Text Key: 124887204
• Report Number: 2024168-2018-08154
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K151317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 1014254-100
• Device Lot Number: 8021241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• 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