STONETOME¿

Report

• Report Number: 3005099803-2018-00224
• Event Type: Malfunction
• Date Received: January 30, 2018
• Report Date: January 1, 2018
• Product Code: LQR
• PMA / PMN Number: K946358
• Report Source: Manufacturer report
• Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

FOR THIS EVENT RELATED TO EXEMPTION NUMBER E2012065 , IT WAS DETERMINED TO HAVE A ROOT CAUSE OF OPERATIONAL CONTEXT.

Description of Event or Problem · 1

THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2012065 FOR PRODUCT CODE LQR. THIS REPORT SUMMARIZES 1 EVENT REPORTED TO BOSTON SCIENTIFIC FOR A STONETOME WIRE BREAK. THE PATIENT'S SEX AND AGE ALONG WITH ALL OTHER DEMOGRAPHIC INFORMATION IS UNKNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
70604	STONETOME¿	DISLODGER, STONE, BILIARY	LQR		M00535150

Patients

Seq	Age	Sex	Outcome	Treatment
1

Terms

Patient problem · 1

• No Consequences Or Impact To Patient

Product problems · 1

• Break

Type of report · 1

• Initial submission