DYNAMIC (Y) STENT M00570680 7068

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 2008-11-11 for DYNAMIC (Y) STENT M00570680 7068 manufactured by Boston Scientific Corporation.

Event Text Entries

[965848] It was reported to boston scientific corp that a dynamic (y) stent device was being placed in a rigid bronchoscopy procedure of the trachea in 2008 (female pt; weight unk). According to the complainant, during the procedure, "the stent fractured and ripped in half. " it was further reported that the stent was removed and the pt was intubated; the procedure was not completed due to this event. There were no pt complications reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


[8227599] Although the suspect device has been received, the evaluation has not been completed. Therefore, the cause of the reported malfunction has not been determined.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005099803-2008-06194
MDR Report Key1226530
Report Source05,07
Date Received2008-11-11
Date of Report2008-10-14
Date of Event2008-10-14
Date Mfgr Received2008-10-14
Device Manufacturer Date2008-02-01
Date Added to Maude2008-11-17
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 ContactKEN HIRAKAWA
Manufacturer Street100 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086836264
Manufacturer G1WILLY RUSCH GMBH, TELEFLEX MEDICAL
Manufacturer StreetWILLY RUSCH STRASSE 4-10
Manufacturer CityKERNEN I.R. 71394
Manufacturer CountryGM
Manufacturer Postal Code71394
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDYNAMIC (Y) STENT
Product CodeNYT
Date Received2008-11-11
Returned To Mfg2008-10-30
Model NumberM00570680
Catalog Number7068
Lot Number000008071
ID NumberNA
Device Expiration Date2013-01-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key1281322
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressMARLBOROUGH MA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2008-11-11

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