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

Model Number	39539
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the coil at the tip peeled off.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery (sfa).A truepath chronic total occlusion device was selected for use.During procedure, it failed to advance to its desired direction.The device was simply removed from the patient's body.When the device was removed from the patient's body, it was noted that the coating of the coil at the tip peeled off and became chipped.The abrasion was due to the device being stuck to the severely calcified lesion, and resistance was felt as pulling ang pushing that caused the abrasion.Also, something hairlike on the tip was observed which appeared to be unraveled coil material at the tip.No device fragments were left inside the patient.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The control unit, motor housing, working length, tip coil, tip housing/tip were visually examined.There was damage to the distal portion of the coil of the tip, as it was stretched and the distal end of the coil of the tip was separated from the hypotube/tip housing and uncoiled; however, the tip was attached and jammed into the tip housing.There was a piece of fibrous fm attached to the stretched coil and hypotube.The fibrous fm was not part of the device and was likely from some kind of surgical cloth used during the procedure.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the coil at the tip peeled off.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery (sfa).A truepath chronic total occlusion device was selected for use.During procedure, it failed to advance to its desired direction.The device was simply removed from the patient's body.When the device was removed from the patient's body, it was noted that the coating of the coil at the tip peeled off and became chipped.The abrasion was due to the device being stuck to the severely calcified lesion, and resistance was felt as pulling ang pushing that caused the abrasion.Also, something hairlike on the tip was observed which appeared to be unraveled coil material at the tip.No device fragments were left inside the patient.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.

• Brand Name: TRUEPATH
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8935767
• Report Number: 2134265-2019-10290
• Device Sequence Number: 502738
• Product Code: PDU
• UDI-Device Identifier: 08714729820284
• UDI-Public: 08714729820284
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/19/2020
• Device Model Number: 39539
• Device Catalogue Number: 39539
• Device Lot Number: 0021908424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE CATHETER: GUIDEZILLAPV; GUIDE CATHETER: GUIDEZILLAPV; INTRODUCER SHEATH: PARENT6FR 48CM; INTRODUCER SHEATH: PARENT6FR 48CM; MICRO CATHETER: PROMINENTRAPTOR; MICRO CATHETER: PROMINENTRAPTOR; GUIDE CATHETER: GUIDEZILLAPV; INTRODUCER SHEATH: PARENT6FR 48CM; MICRO CATHETER: PROMINENTRAPTOR
• Patient Age: 72 YR
• Patient Weight: 71