FDA Adverse Event Injury Summary report: N

JAGWIRE

MDR report key: 1822151 · Received September 1, 2010

Report

Report Number: 3005099803-2010-03745
Event Type: Injury
Date Received: September 1, 2010
Date of Event: August 3, 2010
Report Date: August 10, 2010
Manufacturer: BOSTON SCIENTIFIC - MIAMI
Product Code: EZB
PMA / PMN Number: EXEMPT
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS USED PAST IT'S EXPIRATION DATE. (B)(4)- NO CODE AVAILABLE (ADDITIONAL INTERVENTION REQUIRED). (B)(4) (TIP); (DETACHMENT OF DEVICE OR DEVICE COMPONENT) FOR THE REPORTED EVENT OF TIP DETACHED. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, AT THE END OF THE PROCEDURE WHEN THE DOCTOR EXCHANGED THE GUIDEWIRE, THE FIRST 5CM OF THE DISTAL TIP DETACHED INSIDE THE PATIENT'S BILIARY DUCT. THIS FRAGMENT WAS SUCCESSFULLY REMOVED WITH A DILATATION BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER JAGWIRE GUIDEWIRE. 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 STABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	JAGWIRE	STYLET FOR CATHETER, GASTRO-UROLOGY	EZB	BOSTON SCIENTIFIC - MIAMI	M00556561	11011965

Patients

Seq	Age	Sex	Outcome	Treatment
1	23 YR		Required Intervention