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 01/04/2018

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 was located in the mildly tortuous and severely calcified left superficial femoral artery (sfa).A truepath¿ cto device was selected for use.During preparation, the shape of the tip was not attached yet, and the device was moved by testing whether it works normally.However, two issues occurred.The device turns into alert mode upon operating and not only the tip rotated but the entire wire rotated including all accessories such as torquer rotated together.The usage was then discontinued.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

(b)(4).Device evaluated by mfr., eval summary attached, method codes, result codes, conclusion codes updated.Device evaluated by manufacturer: the device was returned for analysis.Microscopic inspection of the control unit, motor housing and working length and tip/tip housing were performed and revealed that the tip was not shaped.There was saline along on the shaft and tip of the device.There were no damage or irregularities identified during analysis.Functional testing was performed and when the device was turned on it started running at alert level 2 for 30 seconds.Then, after 1 minute the device ran as expected, the normal audible noise was heard, and meanwhile the device vibrated and the burr tip rotated with no alert light or issues.While running, the tip moves back and forth, but not outside of the acceptable range.When pressure was applied and released the alert lights and audible noise worked properly.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 severely calcified left superficial femoral artery (sfa).A truepath¿ cto device was selected for use.During preparation, the shape of the tip was not attached yet, and the device was moved by testing whether it works normally.However, two issues occurred.The device turns into alert mode upon operating and not only the tip rotated but the entire wire rotated including all accessories such as torquer rotated together.The usage was then discontinued.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: 7210468
• MDR Text Key: 98180077
• Report Number: 2134265-2018-00268
• 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: 01/04/2018

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: 10/02/2019
• Device Model Number: H74939208181650
• Device Catalogue Number: 39208-18165
• Device Lot Number: 21343172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2018
• Initial Date FDA Received: 01/22/2018
• Supplement Dates Manufacturer Received: 01/26/2018
• Supplement Dates FDA Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2017
• 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