FDA Adverse Event Malfunction Summary report: N

JAGTOME¿ RX 44

MDR report key: 2834164 · Received November 15, 2012

Report

Report Number: 3005099803-2012-05306
Event Type: Malfunction
Date Received: November 15, 2012
Date of Event: October 23, 2012
Report Date: October 23, 2012
Manufacturer: BOSTON SCIENTIFIC - SPENCER
Product Code: KNS
PMA / PMN Number: K013153
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4) FOR THE REPORTED EVENT: CATHETER TORN. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME WAS USED DURING AN ENDOSCOPIC SPHINCTEROTOMY (EST) PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, AFTER THE EST PROCEDURE WAS PERFORMED WITH THIS DEVICE, THE JAGTOME DEVICE WAS CHECKED, AND THE GUIDEWIRE LUMEN WAS TORN THROUGH TO THE TIP OF THE DEVICE. THE PHYSICIAN CONFIRMED THAT HE/SHE HAD TORN THE DEVICE THROUGH TO THE TIP WITH THE GUIDEWIRE. THE COMPLAINANT ALSO REPORTED THAT DURING THE PROCEDURE, AN RO MARKER FROM A DEVICE OF AN UNKNOWN MANUFACTURER WAS FOUND WITHIN THE COMMON BILE DUCT. THE RO MARKER WAS BELIEVED TO HAVE DETACHED DURING A PREVIOUS ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. NO ATTEMPT WAS MADE TO RETRIEVE THE RO MARKER. 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 "OK".

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	JAGTOME¿ RX 44	UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)	KNS	BOSTON SCIENTIFIC - SPENCER	M00573050

Patients

Seq	Age	Sex	Outcome	Treatment
1