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

Model Number	M0066703061
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2019 as no event date was reported.(b)(4) captures the reportable corewire break.(evaluation conclusion codes): the device has been received for analysis.Upon 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 that a sensor wire guidewire was used in the ureter during a procedure.The procedure date is unknown.According to the complainant, during procedure, the sensor wire was placed in the urinal catheter.Then inserted in the urethral opening and explored, bleeding occurred.The guidewire was removed and examined.It was noted the corewire tip was broken due to this it scratched the ureteral orifice.Reportedly, no treatment was needed for patient for bleeding.
Event or Problem Description
It was reported to boston scientific corporation that a sensor wire guidewire was used in the ureter during a procedure.The procedure date is unknown.According to the complainant, during procedure, the sensor wire was placed in the urinal catheter.Then inserted in the urethral opening and explored, bleeding occurred.The guidewire was removed and examined.It was noted the corewire tip was broken due to this it scratched the ureteral orifice.Reportedly, no treatment was needed for patient for bleeding.Additional iinformation received on 01nov2019: reportedly, it was confirmed in the ultrasonic image that the bleeding was controlled and no treatments were required.Also, the physician noticed that the guidewire appeared thin.
Additional Manufacturer Narrative
Date of event: date of event was approximated to 09/01/2019 as no event date was reported.Patient codes: problem code 1069 captures the reportable corewire break.Investigation results: visual examination of the returned device revealed that the urethane section is bent.Additionally, the core wire tip got detached at the urethane section.The complaint was not consistent with the reported event of broken core wire.Urethane section bent and corewire exposed were known issues caused during manipulation of the device or due to the interaction with other devices.All outer diameters were found within specification.Therefore, the most probable cause of this complaint is adverse event related to procedure, since it is the most likely that adverse event occurred during the procedure and the device had no influence on event.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release to distribution.A labeling review was performed and no anomalies were found.

• Brand Name: SENSOR
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9252369
• Report Number: 3005099803-2019-05313
• Device Sequence Number: 2105053
• Product Code: EZB
• UDI-Device Identifier: 08714729302667
• UDI-Public: 08714729302667
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2019

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: 12/06/2020
• Device Model Number: M0066703061
• Device Catalogue Number: 670-306
• Device Lot Number: 0021480788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 10/29/2019
• Supplement Report FDA Received Date: 11/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1