MAUDE Adverse Event Report: AV-TEMECULA-CT TREK CORONARY DILATATION CATHETER

Catalog Number 1012276-20

Device Problems Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Incorrect anatomy.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.Review of the complaint history identified no other incidents from this lot.The investigation determined the reported complaints appear to be related to user error.It should be noted the trek rx was used to treat the patient's upper extremity, but the trek rx instructions for use states: the trek rx coronary dilatation catheters are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of this device.

Event Description

It was reported that the thrombolysis catheter was advanced through the radial access site to the subclavian artery to treat the patient who had a cold arm with thoracic outlet syndrome.The thrombolysis catheter was meant to be left in the patient's arm, but the thrombolysis catheter blocked the blood flow to the arm.The thrombolysis catheter was removed from the radial access and was meant to be advanced through the femoral access.During advancement to the target artery near the elbow, the 3.5x20 trek rx balloon dilatation catheter had advanced on the fielder guide wire through the subclavian, but resistance was met with the anatomy.The trek interacted with the patient's rib that was sticking out and the trek fractured in two pieces.Only the trek and the guide wire were in the sheath at the time.The separated segment was removed via snare.The patient will be taken to surgery to treat the thoracic outlet syndrome.No additional information was provided.

• Brand Name: TREK CORONARY DILATATION CATHETER
• Type of Device: CORONARY DILATATION CATHETER
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): EL COYOL, COSTA RICA REG# 3009031392; 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: 7580103
• MDR Text Key: 110446138
• Report Number: 2024168-2018-04275
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138584
• UDI-Public: 08717648138584
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 1012276-20
• Device Lot Number: 70913G1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2017
• 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
• Patient Age: 28 YR
• Patient Weight: 79