FDA Adverse Event Malfunction Summary report: N

INTERJECT INJECTION THERAY NEEDLE CATHETER

MDR report key: 1160028 · Received September 12, 2008

Report

Report Number: 3005099803-2008-04510
Event Type: Malfunction
Date Received: September 12, 2008
Date of Event: August 11, 2008
Report Date: August 13, 2008
Manufacturer: BOSTON SCIENTIFIC CORPORATION
Product Code: FCG
PMA / PMN Number: K012864
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SN
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. THE DEVICE HISTORY RECORD FOR THIS LOT WAS REVIEWED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE DID NOT IDENTIFY ANY SIMILAR COMPLAINTS FOR THE REPORTED LOT NUMBER. THE JULY 2008 15-MONTH INTERJECT-SCLEROTHERAPY NEEDLES 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 INTERJECT INJECTION THERAPY NEEDLE CATHETER WAS USED DURING A HEMOSTASIS PROCEDURE, PERFORMED ON TWO DAYS EARLIER. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY EXTENDING THE NEEDLE OUT FROM THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER INTERJECT INJECTION THERAPY NEEDLE CATHETER. 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 "STABLE".

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INTERJECT INJECTION THERAY NEEDLE CATHETER		FCG	BOSTON SCIENTIFIC CORPORATION	M00518351	9639142

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK