MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENSOR NITINOL WIRE WITH HYDROPHILIC; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number M0066703080

Device Problems Break (1069); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/24/2018

Event Type  malfunction  

Event Description

Per the operation room scrub tech: during the procedure, the tip of the sensor wire broke but it was not noted when the tip broke.The scrub tech noted that the sensor wire appeared to be defective after it was removed and placed on his sterile field.It was noted that the tip was missing.The surgeon was informed of issue and after a thorough search found the wire tip in the patient's bladder and removed it.Per the surgeon's dictation, there was a defect of the boston scientific sensor wire: "a 22 french cystoscope was introduced into the bladder and a 6 french-open-ended ureteral catheter was introduced into the right ureter over a 0.035 sensor wire which was advanced through the ureteral catheter into the renal pelvis.A 6 x 26 stent was deemed appropriate size to advance in exchange for the ureteral catheter over the wire however, at the time, for distal ureteral stricture and distal ureteral tortuosity reasons, the stent could not go beyond the distal ureter.A balloon dilator was then used to dilate the distal stricture and straighten out the tortuosity.Then, a balloon could not advance appropriately.Attempts to advance a smaller 5 french stent was unsuccessful.Then, a ureteroscope was used to get access to the ureter to advance over a new wire 0.035 sensor wire which revealed distal ureteral irritation and defect.The sensor wire was exchanged for a 0.025 polytetrafluoroethylene (ptfe) wire due to uncovered defect of the 0.035 wire which may have been the reason for the trouble advancing the stent.With a new ptfe wire a new balloon dilator 15 french by 10 cm was advanced and the distal ureter dilated for 5 minutes.Finally, the dilator which did advance appropriately was removed in exchange for the 6 x 26 french stent that advanced over the 0.025 wire.The distal ureter remained intact and without any perforation or internal defect that was perceptively associated with wire challenges.There was no evidence of contrast extravasation of injury to the visible intravesical ureter.".

• Brand Name: SENSOR NITINOL WIRE WITH HYDROPHILIC
• Type of Device: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 8840660
• MDR Text Key: 152633241
• Report Number: 8840660
• Device Sequence Number: 1
• Product Code: EZB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0066703080
• Device Catalogue Number: M0066703080
• Device Lot Number: 22982731
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20440 DA
• Patient Weight: 82