MAUDE Adverse Event Report: BOSTON SCIENTIFIC HYDRATOME RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC

Model Number RX 44

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2016

Event Type  Injury  

Event Description

During endoscopic retrograde cholangiopancreatography with sphincterotomy and balloon sweep, the hydratome cut wire noted on fluoroscopy had fractured.The fractured piece was not seen on fluoroscopy.The cut wire was removed without incident.The new cut wire was inserted and the procedure was continued and completed.The cut wire and package was retained and is available for return to the boston scientific rep.

• Brand Name: HYDRATOME RX 44
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC
• Manufacturer (Section D): BOSTON SCIENTIFIC; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 5466272
• MDR Text Key: 39223953
• Report Number: 5466272
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/11/2018
• Device Model Number: RX 44
• Device Catalogue Number: M00583040
• Device Lot Number: 18603147
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/10/2016
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 78