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

Model Number M00556590

Device Problems Entrapment of Device (1212); Material Split, Cut or Torn (4008)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/13/2021

Event Type  malfunction  

Event Description

Tip of guidewire tore off when grabbed by a snare during peg-j tube insertion.The tip was left in the patient's stomach.

• Brand Name: JAGWIRE
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 13168062
• MDR Text Key: 283254591
• Report Number: 13168062
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/17/2021

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
• Device Operator: Health Professional
• Device Model Number: M00556590
• Device Catalogue Number: M00556590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27740 DA
• Patient Sex: Male
• Patient Weight: 86 KG