SPYSCOPE ACCESS AND DELIVERY CATHETER M00546230 4623

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2009-08-11 for SPYSCOPE ACCESS AND DELIVERY CATHETER M00546230 4623 manufactured by Boston Scientific Corporation.

Event Text Entries

[1209884] Note: this report pertains to one of two complaints that occurred during the same procedure. Refer to manufacturer report # 3005099803-2009-03811 for the other associated device information. It was reported to boston scientific corporation that a spyscope access and delivery catheter and a spyglass direct visualization probe were used during an ercp (endoscopic retrograde cholangiopancreatography) with electrohydraulic lithotripsy (ehl) procedure performed in 2009. According to the complainant, difficulty was encountered while advancing the spyprobe through the spyscope. The spyprobe appeared to become stuck at the spyscope tip. The spyscope was removed from the patient, but the spyprobe still could not be advanced through the channel. The procedure was not completed due to this event. However, a biliary stent was placed to allow duct drainage until the procedure could be re-scheduled. 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.
Patient Sequence No: 1, Text Type: D, B5


[8350528] The device has been received for analysis. Upon 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.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005099803-2009-03810
MDR Report Key1436711
Report Source05,07
Date Received2009-08-11
Date of Report2009-07-13
Date of Event2009-07-09
Date Mfgr Received2009-07-13
Device Manufacturer Date2009-05-01
Date Added to Maude2009-08-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactCHARLES MONTGOMERY
Manufacturer Street100 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086836132
Manufacturer G1MEDVENTURE TECHNOLOGY CORPORATION
Manufacturer Street2301 CENTENNIAL BLVD.
Manufacturer CityJEFFERSONVILLE IN 47130
Manufacturer CountryUS
Manufacturer Postal Code47130
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSPYSCOPE ACCESS AND DELIVERY CATHETER
Product CodeODF
Date Received2009-08-11
Returned To Mfg2009-08-05
Model NumberM00546230
Catalog Number4623
Lot NumberOML9050503
ID NumberNA
Device Expiration Date2010-05-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressMARLBOROUGH MA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2009-08-11

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