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

Model Number H74939208181650

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 01/10/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the device outer shaft rotated.The chronic total occlusion target lesion was located in the mildly tortuous and mildly calcified superior femoral artery (sfa).A truepath cto device was selected for use.During preparation, when the activate switch of the device was turned on, the collet cap part and the outer shaft rotated while abnormal sound was being heard.Furthermore, the distal tip was not rotating.The sound during alert was heard while the control unit lit up sequentially from green on the left to the red lamp.After that, the connection was checked again but the issue was not resolved.When the physician pushed 3cm of the catheter tip with a finger, abnormal sound and rotation of the outer shaft stopped and the distal tip rotated.The control unit also returned to normal.The device was not used and procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for analysis.Returned product consisted of a truepath device.The control unit, motor housing and working length and tip/tip housing were microscopically examined.There is saline on the tip and the working length.There is coil damaged.Engineering and the cis technician performed functional testing on the device.When the device was turned on the red light flashed and the device did not work.The device was taken apart and the collet was loosened and removed.When the motor housing was removed, saline pooled out of the housing.The motor is severely corroded/rusted due to excessive saline exposure while being handled.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

It was reported that the device outer shaft rotated.The chronic total occlusion target lesion was located in the mildly tortuous and mildly calcified superior femoral artery (sfa).A truepath cto device was selected for use.During preparation, when the activate switch of the device was turned on, the collet cap part and the outer shaft rotated while abnormal sound was being heard.Furthermore, the distal tip was not rotating.The sound during alert was heard while the control unit lit up sequentially from green on the left to the red lamp.After that, the connection was checked again but the issue was not resolved.When the physician pushed 3cm of the catheter tip with a finger, abnormal sound and rotation of the outer shaft stopped and the distal tip rotated.The control unit also returned to normal.The device was not used and procedure was completed with a different device.No patient complications were reported.

• 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: 7231038
• MDR Text Key: 98747070
• Report Number: 2134265-2018-00373
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

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: 09/11/2019
• Device Model Number: H74939208181650
• Device Catalogue Number: 39208-18165
• Device Lot Number: 0021260250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 01/31/2018
• Supplement Dates Manufacturer Received: 02/06/2018
• Supplement Dates FDA Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2017
• 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