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

Model Number M00556581

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Perforation (2001)

Event Date 12/14/2020

Event Type  Death  

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 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
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-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: 11158301
• MDR Text Key: 226522743
• Report Number: 3005099803-2021-00063
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 08714729339151
• UDI-Public: 08714729339151
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: M00556581
• Device Catalogue Number: 5658
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 01/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death