FDA Adverse Event Malfunction Summary report: N

10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890

MDR report key: 1942135 · Received December 30, 2010

Report

Report Number: 3005099803-2010-05404
Event Type: Malfunction
Date Received: December 30, 2010
Date of Event: December 2, 2010
Report Date: December 9, 2010
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: FGE
PMA / PMN Number: K081733
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX UNCOVERED STENT WAS USED DURING A PROCEDURE WITHIN THE BILIARY DUCT ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN HAD BOTH A SCOPE AND GUIDEWIRE IN PLACE. WHILE ATTEMPTING TO ADVANCE THE STENT DELIVERY SYSTEM OVER THE GUIDEWIRE, IT GOT STUCK IN THE WORKING CHANNEL OF THE ENDOSCOPE. THE PHYSICIAN REMOVED THE DELIVERY SYSTEM AND NOTICED THAT THE STENT HAD BEEN DEPLOYED WITHIN THE WORKING CHANNEL OF THE SCOPE. THE PHYSICIAN REMOVED THE SCOPE FROM THE PATIENT AND USED A PAIR OF FORCEPS TO RETRIEVE THE STENT. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH ANOTHER WALLFLEX STENT. 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	10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890	CATHETER, BILIARY, DIAGNOSTIC	FGE	BOSTON SCIENTIFIC - GALWAY	M00570890	13019921

Patients

Seq	Age	Sex	Outcome	Treatment
1