FDA.reportPublic FDA data

MAUDE MDR 1326444

MDR report key
1326444
Report number
3005099803-2008-05770
Event key
0
Event type
3
Date of event
2008-05-06
Date received
2009-02-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
KEN HIRAKAWA
Address
100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US
Phone
508-508-5086
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RX ERCP CANNULA STANDARD TIPENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULABOSTON SCIENTIFIC CORPORATION-SPENCERODDM0054577045770011383065R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-02-260

Event Narratives#

D

Patient 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX ERCP CANNULA STANDARD TIP DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE (MALE PATIENT, AGE AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE NURSE WHEN TRYING TO LOAD THE GUIDEWIRE, COULD NOT GET IT TO PASS THROUGH THE CANNULA. THE PROCEDURE WAS COMPLETED WITH A HYDRATOME RX SPHINCTEROTOME. 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." THIS IS THE SECOND OF TWO DEVICES REPORTED TO MALFUNCTION DURING THIS EVENT. REFER TO MANUFACTURER REPORT # 3005099803-2008-5771 FOR INFORMATION REGARDING THE FIRST DEVICE.

N

Patient 1

ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED OF AND IS NOT AVAILABLE FOR RETURN. A DEVICE EVALUATION CANNOT BE PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. A LOT HISTORY SEARCH WAS PERFORMED AND FOUND NO OTHER COMPLAINTS AGAINST THIS LOT.