FDA Adverse Event Malfunction Summary report: N

PINNACLE PELVIC FLOOR REPAIR KITS

MDR report key: 1960216 · Received January 13, 2011

Report

Report Number: 3005099803-2011-00048
Event Type: Malfunction
Date Received: January 13, 2011
Date of Event: December 20, 2010
Report Date: December 20, 2010
Manufacturer: BOSTON SCIENTIFIC - MARLBOROUGH
Product Code: FTL
PMA / PMN Number: K071957
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A POSTERIOR PELVIC FLOOR REPAIR PROCEDURE USING A PINNACLE POSTERIOR PELVIC FLOOR REPAIR KIT, THE PHYSICIAN PLACED THE FIRST MESH LEG ASSEMBLY THROUGH THE SACROSPINOUS LIGAMENT. AS THE PHYSICIAN USED HEMOSTATS TO TENSION THE MESH LEG ASSEMBLY, THE SUTURE (WITH THE NEEDLE ATTACHED AT THE END) "BROKE OFF NEARLY TO THE DILATOR." REPORTEDLY, NO DEVICE COMPONENTS FELL INTO THE PATIENT CAVITY. ADDITIONALLY, IT WAS DETERMINED THAT THE FIRST MESH LEG ASSEMBLY WAS NOT PROPERLY POSITIONED WITHIN THE PATIENT. IT WAS REPORTED THAT THE PHYSICIAN REMOVED THIS PINNACLE POSTERIOR PELVIC FLOOR REPAIR KIT FROM THE PATIENT AND COMPLETED THE PROCEDURE WITH ANOTHER PINNACLE POSTERIOR PELVIC FLOOR REPAIR KIT, WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "FINE."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PINNACLE PELVIC FLOOR REPAIR KITS	MESH, SURGICAL, POLYMERIC	FTL	BOSTON SCIENTIFIC - MARLBOROUGH	M0068317100	1ML0062105

Patients

Seq	Age	Sex	Outcome	Treatment
1	74 YR