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

Model Number UNK-P-JAGWIRE

Device Problem Defective Device (2588)

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

Event Date 10/22/2020

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a jagwire guidewire was used during an ercp procedure on (b)(6) 2020.During the procedure, the jagwire guidewire malfunctioned.The actual failure is unknown.The procedure was not completed.The patient was brought back to the endoscopy unit in the afternoon and the procedure was completed by another endoscopist.Reportedly, the patient had to stay overnight in the hospital circumstances surrounding this event are unknown.Boston scientific has been unable to obtain additional information regarding the event to date, 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: 11362423
• MDR Text Key: 234339916
• Report Number: 3005099803-2021-00662
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/22/2021

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 Model Number: UNK-P-JAGWIRE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 02/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization