MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRUEPATH; WIRE, GUIDE, CATHETER

Model Number 39539

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/12/2018

Event Type  malfunction  

Event Description

It was reported that the device broke.The chronic total occlusion target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A truepath was selected for use.During procedure, it was noted under fluoroscopy that part of the radiopaque marker of the tip was thin at about 5mm while manipulating.It was then judged to be broken and was simply pulled out from the patient's body.The device was visually inspected outside the patient's body and there were no abnormalities observed.The procedure was completed wit another of the same device.No patient complications were reported and the patient was stable.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of a truepath device.The control unit, motor housing, working length, tip housing/tip were microscopically examined.Saline were present on the shaft and tip of the device.Majority of the proximal end of the coil at the tip was stretched and coil at the distal end of the tip was unraveled.A photo was returned and attached to the complaint record.The photo was reviewed by the personnel from the mg cis (maple grove complaint investigation site) and it was found that the light area is where the confirmed unraveled coil was located on the device.Inspection of the remainder of the device presented no other damage or irregularities.

Event Description

It was reported that the device broke.The chronic total occlusion target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A truepath was selected for use.During procedure, it was noted under fluoroscopy that part of the radiopaque marker of the tip was thin at about 5mm while manipulating.It was then judged to be broken and was simply pulled out from the patient's body.The device was visually inspected outside the patient's body and there were no abnormalities observed.The procedure was completed wit another of the same device.No patient complications were reported and the patient was stable.

• Brand Name: TRUEPATH
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8142085
• MDR Text Key: 129635055
• Report Number: 2134265-2018-63661
• Device Sequence Number: 1
• Product Code: PDU
• UDI-Device Identifier: 08714729820284
• UDI-Public: 08714729820284
• Combination Product (y/n): N
• PMA/PMN Number: K140288
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

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: 02/13/2020
• Device Model Number: 39539
• Device Catalogue Number: 39539
• Device Lot Number: 0021882408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 12/07/2018
• Supplement Dates Manufacturer Received: 12/17/2018
• Supplement Dates FDA Received: 01/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INTRODUCER SHEATH: DESTINATION 6F