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

Model Number M00556601

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/02/2023

Event Type  Injury  

Manufacturer Narrative

(impact codes): imdrf impact code f08 is being used to capture the reportable event of hospitalization or prolonged hospitalization.

Event Description

It was reported to boston scientific corporation that a jagwire was used in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.It was reported that when the jagwire was pulled through, the corewire broke and remained inside the pancreatic duct.Reportedly, the patient stayed longer at the hospital for further observation and was sent for imaging.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a jagwire was used in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.It was reported that when the jagwire was pulled through, the corewire broke and remained inside the pancreatic duct.Reportedly, the patient stayed longer at the hospital for further observation and was sent for imaging.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6 (impact codes): imdrf impact code f08 is being used to capture the reportable event of hospitalization or prolonged hospitalization.Block h10: the returned jagwire was analyzed.Visual analysis and microscopic inspection revealed that the distal tip had almost all the pebax detached, exposing the core wire.Additionally, there is no evidence of core wire being broken.No other problems with the device were noted.With all available information, boston scientific concludes the reported event of core wire break was not confirmed during the product investigation.Based on the condition of the returned device, it is probable that the problem occurred due to excess manipulation of the jagwire.This most likely happened during the procedure when excess force was applied to the device such as during the guidewire insertion through another device or the interaction with the scope, causing the coding to detach.Therefore, the most probable root cause is adverse event related to procedure.

• 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: 17029827
• MDR Text Key: 316203464
• Report Number: 3005099803-2023-02744
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 08714729172154
• UDI-Public: 08714729172154
• Combination Product (y/n): N
• Reporter Country Code: JO
• 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,Followup
• Report Date: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00556601
• Device Catalogue Number: 5660
• Device Lot Number: 0030548602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Weight: 95 KG