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

Model Number	M00556651
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	Pancreatitis (4481)
Date of Event	05/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3 (date of event): date of event was approximated to (b)(6)2023 as no event date was reported.Block h6 (patient codes): patient code e1021 captures the reportable event of pancreatitis.Block h6 (device codes): imdrf device code a0401 captures the reportable event of corewire break.
Event or Problem Description
It was reported to boston scientific corporation that a jagwire was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During the procedure, part of the jagwire detached into the pancreatic duct causing pancreatitis in the patient.It was reported that the patient bought the guidewire in to the site.It was noted that the guidewire expired based on the lot and batch number (m00556651 and 18495289) provided back in 07oct2018.Additionally, according to the distributor this guidewire had not been sold by them.No further information has been obtained despite good faith efforts.

• Brand Name: JAGWIRE
• Common Device Name: 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: 17026151
• Report Number: 3005099803-2023-02833
• Device Sequence Number: 7566022
• Product Code: OCY
• UDI-Device Identifier: 08714729172208
• UDI-Public: 08714729172208
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K141820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/30/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/07/2018
• Device Model Number: M00556651
• Device Catalogue Number: 5665
• Device Lot Number: 0018495289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown