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

Model Number UNK548

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

Patient Problems Hemorrhage/Bleeding (1888); Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to report the upn and lot number; therefore the manufacture date and expiration date are unknown.Technical evolution for diagnosis and treatment of biliary diseases using a newly developed cholangioscope.The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

Note: this manufacturer report pertains to one of two devices used in the same procedure.Refer to manufacturer report # 3005099803-2016-01698 and 3005099803-2016-01711 for the other associated device information.It was reported to boston scientific corporation in a presentation that a stonetome and a jagwire guidewire were used in a study of technical evolution for diagnosis and treatment of biliary diseases using a newly developed cholangioscope.According to the complainant, from august 2012 to december 2014, a total of 430 cases wherein an endoscopic sphincterotomy for bile duct stone were completed.The study found that there were twenty-seven (27) patients experienced pancreatitis, twenty-two (22) of those patients had mild pancreatitis and five (5) patients had moderate pancreatitis.There were also seven (7) patients who had bleeding.As reported, there were no patients who had perforation from those cases.The presentation did not provide any additional information regarding the patients involved in the study.

• Brand Name: JAGWIRE¿
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5710885
• MDR Text Key: 47102539
• Report Number: 3005099803-2016-01711
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• PMA/PMN Number: K141820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/17/2016

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: UNK548
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2016
• Initial Date FDA Received: 06/09/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other