FDA Adverse Event Malfunction Summary report: N

HYDRATOME? RX 44

MDR report key: 3914344 · Received July 3, 2014

Report

Report Number: 3005099803-2014-02433
Event Type: Malfunction
Date Received: July 3, 2014
Report Date: June 12, 2014
Manufacturer: BOSTON SCIENTIFIC - COSTA RICA (COYOL)
Product Code: KNS
PMA / PMN Number: K013153
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE COMPLAINANT WAS UNABLE TO REPORT THE UPN AND LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. HOWEVER, THE COMPLAINANT STATED THAT THE DEVICE WAS USED PRIOR TO THE EXPIRATION DATE. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRATOME RX 44 WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP). EXACT PROCEDURE DATE UNKNOWN. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE THE HYDRATOME WAS COAGULATING INSTEAD OF CUTTING. ADDITIONALLY, NO VISIBLE DAMAGE WAS NOTED TO THE HYDRATOME. A PLASTIC STENT WAS PLACED FOR DRAINAGE AS AN ALTERNATIVE TREATMENT. THE PROCEDURE WAS NOT COMPLETED AND A SECOND ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IS BEING SCHEDULED. IT WAS NOTED THAT ALTHOUGH THE COVIDIEN GENERATOR WAS SET TO CUT MODE IT REMAINED ON COAG MODE . THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
389885	HYDRATOME? RX 44	UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)	KNS	BOSTON SCIENTIFIC - COSTA RICA (COYOL)	M00583040

Patients

Seq	Age	Sex	Outcome	Treatment
1