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

Model Number M00556651

Device Problems Break (1069); Use of Device Problem (1670)

Patient Problem Pancreatitis (4481)

Event Date 05/01/2023

Event Type  Injury  

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 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
• 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: 17026151
• MDR Text Key: 316199194
• Report Number: 3005099803-2023-02833
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 08714729172208
• UDI-Public: 08714729172208
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K141820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/11/2023
• Initial Date FDA Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other