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

Catalog Number 1014254-040

Device Problems Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was performed to treat a lesion in the mid left common iliac artery with heavy tortuosity and heavy calcification.A 3.0 x 40 mm armada 18 percutaneous transluminal angioplasty (pta) balloon catheter was advanced to the lesion with resistance from the anatomy and the balloon ruptured on the first inflation to nominal pressure.Resistance with the anatomy was felt on removal of the ruptured balloon and force was applied.The tip of the pta balloon catheter detached from the shaft, but remained attached by some of the balloon material.The pta balloon catheter was unable to be pulled into the guide catheter and an attempt to snare the tip was unsuccessful.To prevent loss of access with switching to a larger sheath the patient was taken to theatre for a surgical cut down to access the left common iliac artery and remove the tip of the pta balloon catheter.The cut down was performed under general anesthetic.The patient was reported to be stable post procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the investigation determined that the reported difficulties and subsequent treatments were due to case circumstances.It is likely that the resistance during advancement and balloon rupture was the result of the outer surface of the balloon material interacting with the lesion calcification causing the balloon to rupture under pressure.The difficulty removing, and separation likely occurred due to the ruptured balloon material becoming caught on the distal end of the introducer sheath during removal.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Manufacturer Narrative

(b)(4).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.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.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 resulting in rupture.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.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): 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: 8160352
• MDR Text Key: 130214581
• Report Number: 2024168-2018-09630
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup,Followup
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 1014254-040
• Device Lot Number: 8062841
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2018
• 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
• Treatment: GUIDE CATHETER: CXIGUIDE WIRE: 0.018 (V18)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 85 YR