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

Model Number M00556621

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

Patient Problem Septic Shock (2068)

Event Date 04/01/2020

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2020 as the reported event date is in early (b)(6) 2020.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a jagwire guidewire was used during a lithotripsy (stone removal) procedure.The exact procedure date is unknown however it was performed in early (b)(6) 2020.According to the complainant, during the procedure, the corewire broke and about 5mm remained in the liver (s3.) at the end (b)(6), exact date is unknown, the patient was transferred to another hospital due to septic shock.Reportedly, it is unknown if the jagwire contributed to the septic shock and in addition, the jagwire guidewire was used past its expiry date.

• 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: 10181657
• MDR Text Key: 196066832
• Report Number: 3005099803-2020-02430
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 08714729172178
• UDI-Public: 08714729172178
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K141820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2020

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: 12/08/2018
• Device Model Number: M00556621
• Device Catalogue Number: 5662
• Device Lot Number: 0018717591
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2020
• Initial Date FDA Received: 06/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2015
• 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