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 11/27/2017

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 was located in the mildly tortuous and moderately calcified superior femoral artery (sfa).A truepath¿ cto device was selected for use.During preparation, it was noted that the outer shaft rotated instead of the tip.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: 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 was saline along on the shaft and tip of the device.There was no damage or irregularities identified during analysis.Functional testing performed and the device turned on and the normal audible noise was heard, meanwhile 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 device presented no damage or irregularities.Device analysis determined the condition of the returned device was not consistent with the reported information.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 device outer shaft rotated.The chronic total occlusion was located in the mildly tortuous and moderately calcified superior femoral artery (sfa).A truepath¿ cto device was selected for use.During preparation, it was noted that the outer shaft rotated instead of the tip.The procedure was completed with another of the same 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: 7106212
• MDR Text Key: 94806219
• Report Number: 2134265-2017-12241
• 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: 11/27/2017

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: 07/25/2019
• Device Model Number: H74939208181650
• Device Catalogue Number: 39208-18165
• Device Lot Number: 21067583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2017
• Initial Date FDA Received: 12/11/2017
• Supplement Dates Manufacturer Received: 12/15/2017
• Supplement Dates FDA Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2017
• 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