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

Model Number	M00556071
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	12/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem 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 hydra jagwire was used in the esophagus during a esophageal stent placement procedure performed on (b)(6) 2021.During procedure, the hydra jagwire passed through the stenosis and hanaro esophageal stent was placed.An examination was performed immediately after the procedure and confirmed the contrast agent had leaked into the peritoneum.It was noted there was a perforation in the stomach and an emergency operation was performed.In the physician's assessment the guidewire contributed to the perforation however there was no reported malfunction of the device.
Additional Manufacturer Narrative
Correction: h6 (impact code).Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6 (device codes): patient code e2114 captures the reportable event of perforation.Block h6 (impact codes): impact code f19 captures the reportable event of surgical intervention.Block h6: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem 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.
Event or Problem Description
It was reported to boston scientific corporation that a hydra jagwire was used in the esophagus during a esophageal stent placement procedure performed on (b)(6) 2021.During procedure, the hydra jagwire passed through the stenosis and hanaro esophageal stent was placed.An examination was performed immediately after the procedure and confirmed the contrast agent had leaked into the peritoneum.It was noted there was a perforation in the stomach and an emergency operation was performed.In the physician's assessment the guidewire contributed to the perforation however there was no reported malfunction of the device.

• Brand Name: HYDRA JAGWIRE
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13119192
• Report Number: 3005099803-2021-07979
• Device Sequence Number: 4665292
• Product Code: EZB
• UDI-Device Identifier: 08714729648505
• UDI-Public: 08714729648505
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2022

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 Model Number: M00556071
• Device Catalogue Number: 5607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female