FDA Adverse Event Malfunction Summary report: N

SPYGLASS COMPONENT

MDR report key: 1771705 · Received July 28, 2010

Report

Report Number: 3005099803-2010-03246
Event Type: Malfunction
Date Received: July 28, 2010
Date of Event: July 7, 2010
Report Date: July 7, 2010
Manufacturer: BOSTON SCIENTIFIC - MARLBOROUGH
Product Code: KOG
PMA / PMN Number: K052194
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

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 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. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SPYGLASS DIRECT VISUALIZATION PROBE WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY PROCEDURE (ERCP) PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING THE ERCP, AS THE PHYSICIAN WAS ADVANCING THE PROBE THROUGH THE SPYSCOPE ACCESS AND DELIVERY CATHETER SOME RESISTANCE WAS FELT AND THE PROBE SNAPPED IN TWO PIECES. THE PROBE BROKE OUTSIDE THE PATIENT AT THE SMALL CLEAR PLASTIC ENTRY POINT ON THE SPYSCOPE. NO FRAGMENTS DETACHED WITHIN THE PATIENT. THEY REMOVED BOTH THE SPYSCOPE AND SPYGLASS PROBE FROM THE PATIENT AS A UNIT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SPYGLASS COMPONENT	ENDOSCOPE AND/OR ACCESSORIES	KOG	BOSTON SCIENTIFIC - MARLBOROUGH	M00546030

Patients

Seq	Age	Sex	Outcome	Treatment
1	8 YR