MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION HYDRATOME RX 44; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number M00583040

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 01/26/2018

Event Type  malfunction  

Event Description

An elderly patient underwent an ercp (endoscopic retrograde cholangio-pancreatography) with sphincterotomy.During the procedure, the hydratome rx44 would not bow to make the sphincterotomy cut.The cutting wire was noted to be loose at the tip of the hydratome requiring the use of a second hydratome.No harm to patient, no delay in surgery.

• Brand Name: HYDRATOME RX 44
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7450227
• MDR Text Key: 106176936
• Report Number: 7450227
• 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: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/07/2020
• Device Model Number: M00583040
• Device Lot Number: 21361760
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: EVENT OCCURRED DURING PERFORMANCE OF ERCP WITH SPH
• Patient Age: 83 YR
• Patient Weight: 58