FDA Adverse Event Death Summary report: N

SWISS LITHOCLAST ULTRA FLEXIBLE PROBE

MDR report key: 2148450 · Received August 21, 2008

Report

Report Number: 3005099803-2008-02222
Event Type: Death
Date Received: August 21, 2008
Date of Event: September 20, 2005
Report Date: October 20, 2006
Manufacturer: BOSTON SCIENTIFIC CORPORATION
Product Code: FFK
PMA / PMN Number: K002084
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

BOSTON SCIENTIFIC WAS NOTIFIED THAT AN ADVERSE EVENT OCCURRED ON A (B)(4) LITHOCLAST MASTER DEVICE. THIS DEVICE WAS NOT DISTRIBUTED BY BOSTON SCIENTIFIC CORPORATION, HOWEVER, BOSTON SCIENTIFIC DISTRIBUTES A SIMILAR DEVICE WITH THE SAME MFR. THIS EVENT IS BEING REPORTED DUE TO THE DEVICE BEING SIMILAR. ORIGINAL REPORT SENT TO FDA BY E.M.S ELECTRO MEDICAL SYSTEMS S.A. REPORT # 3004096429-2006-00001. (B)(4).

Description of Event or Problem · 1

EMS (B)(6) HAS BEEN INFORMED (B)(6) 2006 BY (B)(6) (DISTRIBUTOR OF (B)(6)) THAT THE PUBLIC ATTORNEY OF (B)(6), IS INVESTIGATING A CASE OF DEATH IN (B)(6) HOSPITAL IN (B)(6) . THE PT PASSED AWAY (B)(6) 2005 AFTER A TREATMENT PCNL IN THE KIDNEY WITH THE (B)(6). AN EXPERT OF (B)(6) INSTALLED THE DEVICE, AND ANOTHER EXPERT WAS PRESENT DURING THE OPERATION. ACCORDING TO INFO PROVIDED BY (B)(6), THE DEVICE WAS IN PERFECT ORDER. BUT COMPLICATION (BLEEDING) OCCURRED AFTER PERFORATION OF THE KIDNEY AND VESSELS AND THE TREATMENT HAD TO BE STOPPED. THE FOLLOWING NIGHT, AN EMERGENCY OPERATION TOOK PLACE, BUT THE PT DID NOT SURVIVE. BASED ON THE INFO PROVIDED, THE DEVICE IS NOT CONSIDERED TO HAVE MALFUNCTIONED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SWISS LITHOCLAST ULTRA FLEXIBLE PROBE		FFK	BOSTON SCIENTIFIC CORPORATION	M0068407390	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Death