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

Model Number	M00556601
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Inflammation (1932)
Date of Event	10/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a jagwire was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2018.According to the complainant, the first ercp procedure was to remove stones and a plastic stent out of the common bile duct.In addition, concrements were also removed which had been discovered by the application of contrast agents in the distal part of the common bile duct.The concrements were removed using a basket and a balloon (manufacturers unknown).They used contrast medium in the first ercp but with catheter, pancreas head and corpus are not selectively displayed without lateral branches.A complete visualization of the pancreatic duct was not intended.There were no reported issues with the jagwire.The patient was stable post-procedure.A day later the patient's cholestasis values increased.Therefore, a second ercp procedure was performed, due to post ercp pancreatitis.Contrast medium was used but a visualization of the pancreatic duct was omitted.A 2cm piece of the jagwire coating was found inside the bile duct, and was successfully retrieved using a balloon catheter (manufacturer unknown).In the physician's assessment, "he cannot say for sure what caused the pancreatitis".

• 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: 8131389
• Report Number: 3005099803-2018-61751
• Device Sequence Number: 16539045
• Product Code: OCY
• UDI-Device Identifier: 08714729172154
• UDI-Public: 08714729172154
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 12/04/2018

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 Expiration Date: 05/01/2021
• Device Model Number: M00556601
• Device Catalogue Number: 5660
• Device Lot Number: 0022069556
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 12/04/2018
• 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: Other
• Patient Age: 34 YR