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

Model Number M00583040

Device Problem Fluid/Blood Leak (1250)

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

Event Date 06/02/2021

Event Type  malfunction  

Event Description

Patient with history of hypertension, diabetes mellitus, hiatal hernia, cholelithiasis with biliary stent and increased abdominal pain times 2 weeks was admitted for an endoscopic retrograde cholangiopancreatography with anesthesia.When prepping for exam, the hydratome¿ rx cannulating sphincterotome was flushed with contrast.The contrast leaked from approx.1 cm above the tip where the cautery wire connects at the end of the sphincterotome.The device was not used on patient.

• Brand Name: HYDRATOME RX 44
• Type of Device: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11990819
• MDR Text Key: 255949223
• Report Number: 11990819
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 08714729755197
• UDI-Public: (01)08714729755197(17)240324(10)27036974
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00583040
• Device Catalogue Number: M00583040
• Device Lot Number: 27036974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/04/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29930 DA
• Patient Weight: 93