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

Model Number	M0066701111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Extravasation (1842); Perforation (2001)
Date of Event	01/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a zebra guidewire was used in the ureter during a holmium laser lithotripsy and double j stent placement procedure performed on (b)(6) 2021.During the procedure, in the physician's assessment the tip of the guidewire may have caused a perforation in the patient's ureter.However, it was reported there was no malfunction with the zebra guidewire.The procedure was completed with this device.Post procedure, on (b)(6) 2021, the patient experienced abdominal pain.A computerized tomography examination revealed urinary exosmosis.It was reported that this caused the boston scientific double j stent to shift in position.The double j tube stent was removed and replaced with a new one.
Event or Problem Description
It was reported to boston scientific corporation that a zebra guidewire was used in the ureter during a holmium laser lithotripsy and double j stent placement procedure performed on (b)(6), 2021.During the procedure, in the physician's assessment the tip of the guidewire may have caused a perforation in the patient's ureter.However, it was reported there was no malfunction with the zebra guidewire.The procedure was completed with this device.Post procedure, on (b)(6), 2021, the patient experienced abdominal pain.A computerized tomography examination revealed urinary exosmosis.It was reported that this caused the boston scientific double j stent to shift in position.The double j tube stent was removed and replaced with a new one.Additional information received on (b)(6), 2021: the stent device was placed after holmium laser lithotripsy.In addition, the zebra guidewire was not used at the same time as the holmium laser.Urinary exosmosis refers to extravasation of urine.Perforation with the zebra wire was not observed under fluoroscopy during the procedure.
Additional Manufacturer Narrative
Block h6 (patient codes): patient code e2114 captures the reportable event of patient's ureter perforation.Patient code e0504 captures the reportable event of patient's extravasation of urine.Block h6 (evaluation conclusion codes): the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.

• Brand Name: ZEBRA
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11880761
• Report Number: 3005099803-2021-02463
• Device Sequence Number: 11648009
• Product Code: EZB
• UDI-Device Identifier: 08714729191247
• UDI-Public: 08714729191247
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/22/2022
• Device Model Number: M0066701111
• Device Catalogue Number: 670-111
• Device Lot Number: 0024479623
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 05/29/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 06/21/2021
• 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: Other
• Patient Age: 22 YR