DYNAMIC Y STENT M00570690

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-04-12 for DYNAMIC Y STENT M00570690 manufactured by Willy Ruesch Gmbh.

Event Text Entries

[42371546] The complainant indicated that the device has been disposed and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed. If any further relevant information is identified, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10


[42371547] Note: this report pertains to one of two devices used within the same patient. Refer to manufacturer report # 3005099803-2016-00963 and 3005099803-2016-00962 for the associated device information. It was reported to boston scientific corporation on (b)(6) 2016, that two dynamic y stents were to be used to treat a stricture in the apex of the main carina and trachea during a procedure performed on (b)(6) 2016. Reportedly, the patient's anatomy was tortuous. During the procedure, the user had difficulty positioning/placing the first dynamic y stent (the subject of mfr. Report# 3005099803-2016-00963). Reportedly, the stent was too stiff and did not conform comfortably to the patient. The dynamic y stent was removed from the patient and a second dynamic y stent (the subject of mfr. Report# 3005099803-2016-00962) was used; however, the same issue occurred and the stent was removed from the patient. 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. Attempts to obtain additional procedure information have been unsuccessful. If any further relevant information is received, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2016-00963
MDR Report Key5569350
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2016-04-12
Date of Report2016-03-17
Date of Event2016-03-15
Date Mfgr Received2016-03-17
Device Manufacturer Date2014-04-03
Date Added to Maude2016-04-12
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 ContactEMP. NANCY CUTINO
Manufacturer Street100 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086834000
Manufacturer G1WILLY RUESCH GMBH
Manufacturer StreetWILLY RUESCH STRASSE 4-10
Manufacturer CityKERNEN 71394
Manufacturer Postal Code71394
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDYNAMIC Y STENT
Generic NamePROSTHESIS, TRACHEAL, EXPANDABLE, POLYMERIC
Product CodeNYT
Date Received2016-04-12
Model NumberM00570690
Lot Number0000014121
Device Expiration Date2019-02-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerWILLY RUESCH GMBH
Manufacturer AddressWILLY RUESCH STRASSE 4-10 KERNEN 71394 71394


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2016-04-12

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.