WANDA?

Report

Report Number: 2134265-2013-03620
Event Type: Malfunction
Date Received: May 29, 2013
Report Date: April 29, 2013
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: LIT
PMA / PMN Number: SIMILAR
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BE
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

DEVICE EVALUATED BY MFR: THE DEVICE WAS RECEIVED COILED INSIDE ITS PROTECTIVE INNER TRAY. THE SEAL OF THE OUTER TRAY WAS PEELED OPEN. THE PROTECTIVE INNER TRAY WAS REMOVED AND EXAMINED AND NO ISSUES WERE NOTED. THE DEVICE WAS FULLY COILED CORRECTLY INSIDE THIS PROTECTIVE TRAY. NO COMPONENTS WERE MISSING. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS 'NOT CONFIRMED' AS THERE IS NO EVIDENCE OF EITHER THE ALLEGED ISSUE OR ANY DEFECT WHICH COULD HAVE CONTRIBUTED TO THE EVENT. (B)(4)

Description of Event or Problem · 1

IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED TREATMENT PROCEDURE, DEVICE STERILITY WAS COMPROMISED. WHILE UNPACKING THE 8.0X40MM WANDA BALLOON CATHETER, IT WAS NOTED THERE "WAS NO PLASTIC COVER" WITHIN THE PACKAGING AND THE BALLOON 'JUMPED' OUT OF THE TRAY ONTO THE FLOOR. THERE WAS NO PATIENT CONTACT, THEREFORE, NO PATIENT COMPLICATIONS WERE REPORTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT PRIOR TO AN UNSPECIFIED TREATMENT PROCEDURE, DEVICE STERILITY WAS COMPROMISED. WHILE UNPACKING THE 8.0X40MM WANDA BALLOON CATHETER, IT WAS NOTED THERE "WAS NO PLASTIC COVER" WITHIN THE PACKAGING AND THE BALLOON 'JUMPED' OUT OF THE TRAY ONTO THE FLOOR. THERE WAS NO PATIENT CONTACT, THEREFORE, NO PATIENT COMPLICATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
237397	WANDA?	CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL	LIT	BOSTON SCIENTIFIC - GALWAY	H965SCH505160	15131545

Patients

Seq	Age	Sex	Outcome	Treatment
1