MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIVA ID TRACTIP; POWERED LASER SURGICAL INSTRUMENT

Model Number	M006R8403960
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Medical device problem code a1005 captures the reportable event of fiber connector overheats.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on august 3, 2021 that a flexiva id tractip 200 laser fiber was used in a cystoscopy, right retrograde ureterogram and pyelogram, right pyeloscopy with laser lithortipsy and placement of a 6x24 double-j ureteral stent procedure performed on (b)(6) 2021.During the procedure, the laser fiber was not working properly and the hub where the fiber was attached to the surgical laser system was heating up.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: FLEXIVA ID TRACTIP
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12380159
• Report Number: 3005099803-2021-04426
• Device Sequence Number: 19862533
• Product Code: GEX
• UDI-Device Identifier: 08714729963837
• UDI-Public: 08714729963837
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K110685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2021

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 Model Number: M006R8403960
• Device Catalogue Number: 69270
• Device Lot Number: 0000019045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 112