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 2009-09-10 for DYNAMIC Y STENT M00570680 7068 manufactured by Boston Scientific Corporation.

Event Text Entries

[1138204] Note: this report pertains to one of three complaints that occurred during the same procedure. Refer to manufacturer report # 3005099803-2009-xxxxx and # 3005099803-2009-xxxxx for the other associated device information. It was reported to boston scientific corporation that three dynamic y stents were used during an esophageal tracheal fistula stenting procedure performed on the event date, (50+ patient). According to the complainant, the physician successfully placed a 15 x 12mm stent in a tracheal esophageal fistula in a pt with late stage cancer. However, the physician felt the stent was too large in size for the pt and removed it. The physician then placed a smaller, 12 x 10mm, stent successfully. However, the tumor began to bleed. The physician removed the stent, controlled the bleeding, and successfully placed an 11 x 8mm stent. Again, the bleeding resumed and the stent was removed. The physician had wanted to leave the stent in place; however, the anesthesiologist felt the stent should be removed in order to more effectively suction the bleed. The procedure was aborted at that time. This procedure was perceived as a last ditch effort for this extremely ill pt. The physician did not believe the stents were mislabeled, rather the difficulty was the result of the pt's anatomy. The pt's condition at the conclusion of the procedure was reported to be stable. The physician is no longer treating the pt.
Patient Sequence No: 1, Text Type: D, B5


[8476626] No device malfunction reported. The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed. If there is any further relevant information, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005099803-2009-04279
MDR Report Key1469268
Report Source05,07
Date Received2009-09-10
Date of Report2009-08-12
Date of Event2009-07-30
Date Mfgr Received2009-08-12
Device Manufacturer Date2008-12-01
Date Added to Maude2009-09-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactCHARLES MONTGOMERY
Manufacturer Street100 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086836132
Manufacturer G1WILLY RUESCH GMBH
Manufacturer StreetWILLY RUESCH STRASSE 4-10
Manufacturer CityKERNEN 71394
Manufacturer Postal Code71394
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDYNAMIC Y STENT
Product CodeNYT
Date Received2009-09-10
Model NumberM00570680
Catalog Number7068
Lot Number0000008491
ID NumberNA
Device Expiration Date2013-11-30
OperatorHEALTH PROFESSIONAL
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressMARLBOROUGH MA US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2009-09-10

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