FDA Adverse Event Malfunction Summary report: N

RESOLUTION HEMOSTASIS CLIPPING DEVICE

MDR report key: 1133473 · Received August 22, 2008

Report

Report Number: 3005099803-2008-03816
Event Type: Malfunction
Date Received: August 22, 2008
Date of Event: July 23, 2008
Report Date: July 23, 2008
Manufacturer: BOSTON SCIENTIFIC CORPORATION
Product Code: KOD
PMA / PMN Number: K040148
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: PHARMACIST

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE HAS NOT BEEN RETURNED. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE PERTINENT LOT WAS PERFORMED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE DID NOT IDENTIFY ANY SIMILAR COMPLAINTS FOR THE SAME LOT NUMBER. THE 2008, HEMOSTATIC CLIPPING PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND NOTED.

Description of Event or Problem · 1

IN 2008, IT WAS REPORTED THAT A PROCEDURE USING A HEMOSTATIC CLIPPING DEVICE OCCURRED. ACCORDING TO THE COMPLAINANT, THE HEMOSTATIC CLIP REMAINED BLOCKED IN THE SHEATH AND COULD NOT DEPLOY. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT AND THE PT'S CONDITION WAS REPORTED AS "OK".

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	RESOLUTION HEMOSTASIS CLIPPING DEVICE		KOD	BOSTON SCIENTIFIC CORPORATION	M00522610	0ML8041608

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK