ULTRAFLEX COVERED NG ESOPHAGEAL STENT

Report

Report Number: 3005099803-2008-00263
Event Type: Malfunction
Date Received: March 12, 2008
Date of Event: January 18, 2008
Report Date: February 13, 2008
Manufacturer: BOSTON SCIENTIFIC IRELAND, LTD
Product Code: ESW
PMA / PMN Number: K032910
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE COMPLAINANT STATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A DEVICE ANALYSIS CANNOT BE PERFORMED; THEREFORE, THE RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT IS UNDETERMINED. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED FOR THE LOT. THE 02/2008 15-MONTH ULTRAFLEX ESOPHAGEAL STENT PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

Description of Event or Problem · 1

ON 02/13/2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT AN ULTRAFLEX COVERED NG ESOPHAGEAL STENT WAS USED DURING A "STENT IN STENT" PLACEMENT PROCEDURE (PATIENT AGE, GENDER AND WEIGHT UNK) ON THE MONTH BEFORE. ACCORDING TO THE COMPLAINANT, WHILE ATTEMPTING TO PLACE THE STENT IN ANOTHER STENT "TO COVER THE DISTAL AREA (FISTULA) OF A PREVIOUS IMPLANTED STENT, IT WAS DIFFICULT TO PULL THE (SUTURE) THREAD AND THE (STENT) DID NOT OPEN NORMALLY BUT HAD THE FORM OF A TWISTED BALL... (UPON) RELEASING THE STENT, THE THREAD RIPPED AND THE DR REMOVED THE WHOLE CATHETER AND THE TWISTED DISTAL END OF THE STENT, TOGETHER WITH THE PREVIOUS STENT, OUT OF THE PT... THE DOCTOR IMPLANTED ANOTHER ULTRAFLEX (COVERED NG ESOPHAGEAL STENT) WITH GOOD RESULTS." AT THE CONCLUSION OF THE PROCEDURE, THE PT'S CONDITION WAS REPORTED AS "OKAY".

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ULTRAFLEX COVERED NG ESOPHAGEAL STENT		ESW	BOSTON SCIENTIFIC IRELAND, LTD	M00514210	9325105

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK