FDA Adverse Event Malfunction Summary report: N

INJECTION GOLD PROBE BIPOLAR CATHETER

MDR report key: 1052727 · Received May 23, 2008

Report

Report Number: 3005099803-2008-00547
Event Type: Malfunction
Date Received: May 23, 2008
Date of Event: April 16, 2008
Report Date: April 23, 2008
Manufacturer: BOSTON SCIENTIFIC CORPORATION
Product Code: KNS
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: HI, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE SUSPECT DEVICE HAS BEEN RETURNED, BUT THE DEVICE EVALUATION IS NOT COMPLETE; THEREFORE, THE CAUSE OF THE ELECTRICAL FAILURE (UNABLE TO CAUTERIZE) IS UNDETERMINED. A SEARCH OF THE COMPLAINT DATABASE REVEALED NO ADDITIONAL COMPLAINTS RECORDED FOR THIS LOT. THE APRIL 2008 15-MONTH INJECTION GOLD PROBE HEMOSTASIS CATHETER PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008 THAT AN INJECTION GOLD PROBE BIPOLAR CATHETER WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE IN A FEMALE PT ABOUT 7 DAYS PRIOR. ACCORDING TO THE COMPLAINANT, A POLYP WAS REMOVED USING BIOPSY FORCEPS (MFR UNK), AND THE SITE CONTINUED TO BLEED. THE PHYSICIAN ATTEMPTED TO CAUTERIZE THE AREA WITH AN INJECTION GOLD PROBE BIPOLAR CATHETER. THE DEVICE WOULD NOT CAUTERIZE. "ALL CONNECTIONS DOUBLE CHECKED." THE PHYSICIAN USED A SECOND INJECTION GOLD PROBE BIPOLAR CATHETER TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NOTE: MFR REPORT# 3005099803-2008-00534 ADDRESSES THE BIOPSY FORCEPS DEVICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INJECTION GOLD PROBE BIPOLAR CATHETER		KNS	BOSTON SCIENTIFIC CORPORATION	M00560071	11430777

Patients

Seq	Age	Sex	Outcome	Treatment
1	79 YR