MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) JAGWIRE¿; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number	M00556611
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	08/30/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.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
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2017-02798 and 3005099803-2017-02884 for the associated device information.It was reported to boston scientific corporation on (b)(6) 2017 that a jagwire guidewire was used together with a wallflex duodenal soft uncovered stent which was implanted to treat a severe stenosis due to a duodenal tumor from the duodenal bulb to the descending limb of the duodenum during a stent placement procedure performed on (b)(6) 2017.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the physician had difficulty advancing the guidewire (the subject of mfr.Report#3005099803-2017-02884) through the stenosis, which reportedly took about 90 minutes.After the stent (the subject of this report) was successfully implanted, the physician performed fluoroscopy to check the stent's placement.It was noted that the contrast media near the horizontal limb of the duodenum was not clear around the duodenum and the physician suspected that there was a perforation.A computed tomography (ct) scan was performed and it was determined that the contrast media in the retroperitoneum was leaking.Reportedly, the perforation can be managed with anti-body drugs and no other interventions were required.The physician left the stent in place and the procedure was completed.In the physician¿s assessment the guidewire and/or the stent were related to the perforation.

• Brand Name: JAGWIRE¿
• Common Device Name: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 6883872
• Report Number: 3005099803-2017-02884
• Device Sequence Number: 484005
• Product Code: OCY
• UDI-Device Identifier: 08714729172161
• UDI-Public: 08714729172161
• Combination Product (Y/N): N
• PMA/510(K) Number: K141820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/30/2017

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: M00556611
• Device Catalogue Number: 5661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 09/21/2017
• 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: Required Intervention