MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION JAGWIRE; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number	M00556581
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Perforation (2001)
Date of Event	12/14/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
(age at time of event): the exact age of the patient is unknown.However, it was reported the patient was over 18 years old.(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 jagwire and extractor pro were used in the colon during a wallflex colonic metal stent placement procedure performed on (b)(6) 2020.According to the complainant, the physician initially used an egd scope to check the tumor/stricture, then used a jagwire and extractor pro through an adult colonoscope to gain access through the stricture.The balloon was advanced down the guidewire and entered the biopsy channel of the scope however it did not exit the distal tip.Access was lost and the guidewire slipped out of the stricture.At this point, only the guidewire was in the colonoscope.A perforation occurred when the physician repositioned the scope near the tumor.It is unknown what caused the perforation.At that point the patient was sent to surgery.The patient died, however, it is unknown if it happened during or after the surgery.There is no information regarding the cause of the patient's death, and autopsy results were not made available.Reportedly, the patient had a malignant tumor in the colon, but no additional information has been provided.

• Brand Name: JAGWIRE
• Common Device Name: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11158301
• Report Number: 3005099803-2021-00063
• Device Sequence Number: 608216
• Product Code: OCY
• UDI-Device Identifier: 08714729339151
• UDI-Public: 08714729339151
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K141820
• 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
• Report Date (Section B): 01/12/2021

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 Model Number: M00556581
• Device Catalogue Number: 5658
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 01/13/2021
• 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: Death