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

Catalog Number 1012278-20

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Internal file number - (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.It should be noted that the 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, for the purpose of improving myocardial perfusion, balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with st-segment elevation myocardial infarction and balloon dilatation of a stent after implantation.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.The investigation was unable to determine a conclusive cause for the reported difficulty positioning and removing the guide wire; however, the reported separation appears to be related to operational context due to the reported difficulty removing the balloon catheter from the guide wire.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.

Event Description

It was reported the procedure was performed in the internal carotid.A 4.0 x 20 mm trek balloon catheter could not advance over the guide wire, and strong resistance was felt during withdrawal of the device.The balloon catheter was removed but the part of the distal shaft (including the balloon) had separated and remained inside the patient.The distal shaft was surgically removed during removal of a carotid stent in the internal artery.No additional information was provided.

Manufacturer Narrative

(b)(4).

Event Description

Additional information received indicating that two non-abbott carotid stents were implanted during the procedure and both were removed surgically.

• 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): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 7109172
• MDR Text Key: 94543674
• Report Number: 2024168-2017-09620
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08717648138720
• UDI-Public: 08717648138720
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K103110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1012278-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2017
• 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
• Treatment: SHEATH: 8 FR.
• Patient Outcome(s): Hospitalization; Required Intervention