FDA Adverse Event Malfunction Summary report: N

JAG PRECURSOR

MDR report key: 867811 · Received June 20, 2007

Report

Report Number: 6000123-2007-00026
Event Type: Malfunction
Date Received: June 20, 2007
Date of Event: May 26, 2007
Report Date: May 28, 2007
Manufacturer: BOSTON SCIENTIFIC
Product Code: EZB
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. THE DEVICE HISTORY RECORD REVIEW, PRODUCT EVALUATION, AND COMPLAINT TREND ANALYSIS ARE IN PROGRESS; RESULTS WILL BE PROVIDED IN A FOLLOW-UP MEDWATCH REPORT.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2007, THAT DURING AN ENDOSCOPIC RETROGRADE BILIARY DRAINAGE USING A JAG PRECURSOR APPROXIMATELY 1CM OF THE COATING PEELED AND "WAS FOUND TO BE DETACHED" 2CM FROM TIP. THE PHYSICIAN DID NOT RETRIEVE THE COATING AND IS "OBSERVING THE PATIENT'S CONDITION WITH LEAVING THE PEELED COATING INSIDE THE PATIENT". THE PATIENT'S CONDITION WAS REPORTED AS "GOOD".

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	JAG PRECURSOR		EZB	BOSTON SCIENTIFIC	M0055660011	7642693

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK YR