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

Model Number	M006R8403920
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During ureteroscopy with laser lithotripsy, holmium laser fibers x3 broke during surgery.Flexiva id trac tip 200 fiber x2 (lots # 0000006252 and 6261) broke prior to use on patient.These were not used.Flexiva id 365 fiber (lot # 0000006265) broke in the lithovue disposable ureteroscope and a piece of the fiber went into the right kidney.A new flexible lithovue ureteroscope was opened and the piece was retrieved by basket extraction from the right kidney.All fibers were kept as well as the retrieved piece of fiber from the kidney.There was also another flexiva package in which the wire was popped out of the package before it was opened, lot # 0000006205.Procedural note: "the stricture dilated well.The wire was exchanged for an amplatz superstiff wire and the lithobid ureteroscope was placed.It passed easily through the stricture up into the level of the kidney.The kidney was very hydronephrotic.A 365m holmium laser fiber was used to fragment the multiple stones that were seen in the very small pieces.At one point the fiber did break and actually a piece of fiber broke off.Fortunately, i was able to use a 0 tip basket and retrieve it and remove it in its entirety." "the patient tolerated the procedure well.There were no complications.".

• Brand Name: FLEXIVA ID
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7905068
• Report Number: 7905068
• Device Sequence Number: 13873908
• Product Code: GEX
• UDI-Device Identifier: 08714729963776
• UDI-Public: (01)08714729963776(17)210702(10)0000006265
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/14/2018
• Report Date (Section F): 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M006R8403920
• Device Lot Number: 0000006265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 79
• Date Report Sent to FDA: 09/21/2018