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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Notes: this report pertains to two spyscope ds ii, one spy ds controller and two jagwires used during the same procedure.It was reported to boston scientific corporation that two spyscope ds ii, one spy ds controller and two jagwire guidewires were used in the biliary tract during a cholangioscopic lithotripsy procedure performed on (b)(6) 2022.During the procedure, the physician put a spyscope and a jagwire into the biliary tract.During the exchange, the jacket on the guidewire stripped away from the inner shaft.The spyscope could not be back loaded over the guidewire.A new jagwire was used to cannulate again.When cannulation was done and the physician tried to exchange the wire, the wire stripped again.The physician took out the spyscope with the guidewire and decided not to proceed with the use of a guidewire.Then the spyscope was reinserted and during water injection, the spyscope stopped working.The spyscope was replaced with a second spyscope but the same problem occurred.It is unknown if the physician was blasting stones or injecting water when the second spyscope stop working.The procedure was changed to a regular endoscopic retrograde cholangiopancreatography (ercp).A plastic stent was placed.The procedure was not completed due to these events.
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Block h6 (impact codes): impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Block h10: the returned jagwire guidewire was analyzed.The ptfe jacket was peeled at the distal section.Therefore, the reported complaint is confirmed.Based on the condition of the returned device, engineers determined that the problem observed could be due to the manipulation during the procedure.It is likely to happened due to normal use of the device, during insertion into the scope or in the interaction with another device.If additional force was applied during procedure, this could lead to ptfe damaged.Boston scientific has determined the most probable cause of this complaint is adverse event related to procedure.It is most likely that the adverse event occurred during the procedure and the device had no influence on event which led to the reported event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
Notes: this report pertains to two spyscope ds ii, one spy ds controller and two jagwires used during the same procedure.It was reported to boston scientific corporation that two spyscope ds ii, one spy ds controller and two jagwire guidewires were used in the biliary tract during a cholangioscopic lithotripsy procedure performed on march 31, 2022.During the procedure, the physician put a spyscope and a jagwire into the biliary tract.During the exchange, the jacket on the guidewire stripped away from the inner shaft.The spyscope could not be back loaded over the guidewire.A new jagwire was used to cannulate again.When cannulation was done and the physician tried to exchange the wire, the wire stripped again.The physician took out the spyscope with the guidewire and decided not to proceed with the use of a guidewire.Then the spyscope was reinserted and during water injection, the spyscope stopped working.The spyscope was replaced with a second spyscope but the same problem occurred.It is unknown if the physician was blasting stones or injecting water when the second spyscope stop working.The procedure was changed to a regular endoscopic retrograde cholangiopancreatography (ercp).A plastic stent was placed.The procedure was not completed due to these events.

• 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 morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14244778
• Report Number: 3005099803-2022-02345
• Device Sequence Number: 11873621
• Product Code: OCY
• UDI-Device Identifier: 08714729172154
• UDI-Public: 08714729172154
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/03/2024
• Device Model Number: M00556601
• Device Catalogue Number: 5660
• Device Lot Number: 0027966747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2022
• Supplement Date Received by Manufacturer: 05/29/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 06/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Race: White