MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK TRUEPATH¿; WIRE, GUIDE, CATHETER

Model Number H74939208181650

Device Problems Device Markings/Labelling Problem (2911); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).

Event Description

It was reported that the outer shaft of the device was spinning and the tip of the device was not visible under fluoroscopy.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified right superficial femoral artery.A truepath¿ cto device was selected for use.During procedure, the device advanced to some extent.However, it was noted that the tip of the shaft with the radiopaque marker looked transparent under fluoroscopy.When the tip was checked, the outer shaft was noted to be moving.The procedure was completed with a different device.No patient complications were reported and patient's status was good.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of a truepath device without the control unit.Functional testing performed using a test control unit and the device turned on and the normal audible noise was heard.The device vibrated and the burr tip rotated with no alert light or issues.When pressure was applied and released the alert lights and audible noise worked properly.Inspection of the remainder of the device presented no other damage or irregularities.Damage or irregularities contributing to the reported tip not visible under fluoroscopy could not be confirmed because the clinical circumstances could not be replicated.The investigation conclusion is not confirmed - returned as there was no evidence of either the alleged issue(s) or any defect which could have contributed to the event.(b)(4).

Event Description

It was reported that the outer shaft of the device was spinning and the tip of the device was not visible under fluoroscopy.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified right superficial femoral artery.A truepath cto device was selected for use.During procedure, the device advanced to some extent.However, it was noted that the tip of the shaft with the radiopaque marker looked transparent under fluoroscopy.When the tip was checked, the outer shaft was noted to be moving.The procedure was completed with a different device.No patient complications were reported and patient's status was good.

• Brand Name: TRUEPATH¿
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7186929
• MDR Text Key: 97583195
• Report Number: 2134265-2017-13251
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K101599
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2019
• Device Model Number: H74939208181650
• Device Catalogue Number: 39208-18165
• Device Lot Number: 21014953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/25/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2017
• Initial Date FDA Received: 01/12/2018
• Supplement Dates Manufacturer Received: 01/19/2018
• Supplement Dates FDA Received: 02/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2017
• 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