SPYSCOPE DS M00546600 4660

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-02-08 for SPYSCOPE DS M00546600 4660 manufactured by Boston Scientific Corporation.

Event Text Entries

[135523267] Patient's exact age is unknown; however it was reported that the patient was over the age of 18. (b)(4). Although the suspect device has been received, the evaluation has not been completed. Therefore, the cause of the reported malfunction has not been determined. Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10


[135523268] It was reported to boston scientific corporation that a spyscope digital access and delivery catheter was used in the bile duct during a bile duct direct view biopsy procedure performed on (b)(6) 2019. According to the complainant, during the procedure, the working channel sleeve of the spyscope ds protruded. The procedure was still completed with this device. There were no patient complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2019-00603
MDR Report Key8320053
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-02-08
Date of Report2019-03-20
Date of Event2019-01-17
Date Mfgr Received2019-02-27
Device Manufacturer Date2018-09-04
Date Added to Maude2019-02-08
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 FDA3
Event Location3
Manufacturer ContactCAROLE MORLEY
Manufacturer Street300 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086834015
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer Street780 BROOKSIDE DRIVE
Manufacturer CitySPENCER IN 47460
Manufacturer CountryUS
Manufacturer Postal Code47460
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSPYSCOPE DS
Generic NameCHOLEDOCHOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
Product CodeFBN
Date Received2019-02-08
Returned To Mfg2019-01-30
Model NumberM00546600
Catalog Number4660
Lot Number0022604359
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
10 2019-02-08

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