MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) SENSOR PTFE-NITINOL GUIDEWIRE; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number	M0066703120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.Device problem code relates to the device component code for the reported event of core wire broken.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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a sensor guidewire was used in the right kidney during a cystoscopy procedure performed on (b)(6) 2018.According to the complainant, during procedure when they were performing a percutaneous nephrolithotomy (pcnl), this sensor guidewire was passed down.The distal coating seemed to dissolve and the wire that was left was shredded and broke into pieces.One piece broke off, a 4.5 centimeters long and retained was in the patient they tried to retrieve it but there was too much blood in the kidney.They held off the retrieval for a week until the patient did some healing and then went back to get it.Reportedly, "the doctor didn¿t seem concerned at all." attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported to boston scientific corporation that a sensor guidewire was used in the right kidney during a cystoscopy procedure performed on (b)(6) 2018.According to the complainant, during procedure when they were performing a percutaneous nephrolithotomy (pcnl), this sensor guidewire was passed down.The distal coating seemed to dissolve and the wire that was left was shredded and broke into pieces.One piece broke off, a 4.5 centimeters long and retained was in the patient they tried to retrieve it but there was too much blood in the kidney.They held off the retrieval for a week until the patient did some healing and then went back to get it.Reportedly, "the doctor didn¿t seem concerned at all." attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.Additional information received on march 20, 2018: a second surgery was required and was performed a week later to remove the detached pieces of the guidewire.
Additional Manufacturer Narrative
This event was reported to the fda via a voluntary medwatch report.The report number is mw5075537.

• Brand Name: SENSOR PTFE-NITINOL GUIDEWIRE
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7343559
• Report Number: 3005099803-2018-00877
• Device Sequence Number: 709187
• Product Code: EZB
• UDI-Device Identifier: 08714729376385
• UDI-Public: 08714729376385
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0066703120
• Device Catalogue Number: 670-312
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 03/15/2018
• Supplement Report FDA Received Date: 04/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention