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MAUDE MDR 239506

MDR report key
239506
Report number
6000048-1999-00013
Event key
0
Event type
3
Date of event
1998-12-21
Date received
1999-09-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PASSAGE BILIARY DILATATION CATHETERDILATATION CATHETERMICROVASIVE ENDOSCOPY A DIV OF BOSTON SCIENTIFIC CORP.GCCNA50201796777K833417NYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11999-09-0101. R

Event Narratives#

D

Patient 1

IT WAS REPORTED ON 12/28/1998 THAT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY PROCEDURE, THE PHYSICIAN COULD NOT SEE THE RADIOPAQUE MARKERS ON A PASSAGE BILIARY DILATION CATHETER AND SUBSEQUENTLY PERFORATED THE PTS BILE DUCT. THE PRODUCT WAS NOT RETURNED FOR EVAL. AN EVAL OF THE DEVICE REVEALED THAT TWENTY PERCENT OF THE RADIOPAQUE MARKERS WERE MISSING AND POSSIBLY RUBBED OFF OF THE DEVICE. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.