SPYGLASS DIRECT VISUALIZATION SYSTEM

Report

Report Number: 3005099803-2012-01036
Event Type: Injury
Date Received: March 19, 2012
Date of Event: February 24, 2012
Report Date: February 27, 2012
Manufacturer: BOSTON SCIENTIFIC - MARLBOROUGH
Product Code: ODF
PMA / PMN Number: K090170
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4):THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN.THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND 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

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYSCOPE ACCESS AND DELIVERY CATHETER WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE ON (B)(6), 2012. ACCORDING TO THE COMPLAINANT, DURING THE ERCP PROCEDURE THE PHYSICIAN REPORTED THAT A SMALL YELLOW TUBULAR PIECE OF PLASTIC WAS FOUND IN THE PATIENT. PRIOR TO THE FRAGMENT BEING FOUND, A RX EXTRACTION BALLOON AND OLYMPUS SCOPE HAD BEEN USED WITH NO REPORTED MALFUNCTIONS. THE PHYSICIAN CLAIMS THAT THE FRAGMENT HAD DETACHED FROM THE SPYSCOPE, HOWEVER COULD NOT REPORT ANY VISIBLE DAMAGE TO THE DEVICE. THE FRAGMENT WAS UNABLE TO BE RECOVERED AND WAS PASSED IN THE PATIENT'S STOOL. THE PROCEDURE WAS COMPLETED WITH THE SAME SPYSCOPE WITH NO PATIENT COMPLICATIONS. THERE WERE NO ISSUES OR HARM TO THE PATIENT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SPYGLASS DIRECT VISUALIZATION SYSTEM	MINI ENDOSCOPE, GASTROENTEROLOGY-UROLOGY	ODF	BOSTON SCIENTIFIC - MARLBOROUGH	M00546230

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention