FDA Adverse Event Malfunction Summary report: N

SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205

MDR report key: 1863884 · Received October 11, 2010

Report

Report Number: 3005099803-2010-04210
Event Type: Malfunction
Date Received: October 11, 2010
Date of Event: September 22, 2010
Report Date: September 22, 2010
Manufacturer: BOSTON SCIENTIFIC - SPENCER
Product Code: MND
PMA / PMN Number: K020824
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: ZA
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

(B)(4) (FAILURE TO MAINTAIN GRASP).THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem · 1

NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT 3005099803-2010-04257 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO SPEEDBAND SUPERVIEW SUPER 7 MULTIPLE BAND LIGATORS WERE USED DURING AN ESOPHAGEAL VARICES BANDING PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THEY PLACED FOURTEEN BANDS SUCCESSFULLY HOWEVER; THE PATIENT COUGHED AND MOST OF THE BANDS FELL OFF. IT WAS REPORTED THAT THE BANDS WERE LEFT INSIDE THE PATIENT TO PASS NATURALLY. THE CASE WAS COMPLETED WITH A WILSON COOK BANDER. 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	SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205	LIGATOR, ESOPHAGEAL	MND	BOSTON SCIENTIFIC - SPENCER	M00542250	13541686

Patients

Seq	Age	Sex	Outcome	Treatment
1