FDA Adverse Event Malfunction Summary report: N

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

MDR report key: 1832329 · Received September 13, 2010

Report

Report Number: 3005099803-2010-03913
Event Type: Malfunction
Date Received: September 13, 2010
Report Date: August 19, 2010
Manufacturer: BOSTON SCIENTIFIC - SPENCER
Product Code: MND
PMA / PMN Number: K020824
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SC, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

PATIENT INFORMATION UNKNOWN. EVENT DATE UNKNOWN. 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 3005099803-2010-03904 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 A PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IN BOTH INSTANCES, IT WAS REPORTED THAT THE DEVICES WERE NOT LOADING PROPERLY. WHEN THEY DEPLOYED THE BANDS, THE BANDS DID NOT DEPLOY PROPERLY. IT IS UNKNOWN WHAT WAS USED TO COMPLETE THE PROCEDURE. ATTEMPTS TO OBTAIN MORE COMPLETE INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

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	M00542253	13468380

Patients

Seq	Age	Sex	Outcome	Treatment
1