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

Model Number	M00556581
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Impact code: (b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a jagwire as being used in common bile duct during ercp and removal of stones procedure performed on (b)(6) 2022.During the procedure, the physician used a stone retrieval exactor balloon in the common bile duct over the guidewire.At the time of retraction of the guidewire, the physician noticed a small fragment on the x-ray.They pulled out the guidewire and saw that a part of it was peeled off.It was reported that the coating on the tip was not activated using saline before inserting.The procedure was cancelled due to this event.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6 (impact codes): impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.Block h6 (evaluation conclusion codes): the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.
Event or Problem Description
It was reported to boston scientific corporation that a jagwire as being used in common bile duct during ercp and removal of stones procedure performed on (b)(6) 2022.During the procedure, the physician used a stone retrieval exactor balloon in the common bile duct over the guidewire.At the time of retraction of the guidewire, the physician noticed a small fragment on the x-ray.They pulled out the guidewire and saw that a part of it was peeled off.It was reported that the coating on the tip was not activated using saline before inserting.The procedure was cancelled due to this event.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 13929156
• Report Number: 3005099803-2022-01654
• Device Sequence Number: 20396137
• Product Code: OCY
• UDI-Device Identifier: 08714729339151
• UDI-Public: 08714729339151
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2022

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 Model Number: M00556581
• Device Catalogue Number: 5658
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2022
• Supplement Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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