STONETOME M00535190 3519

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 2019-04-16 for STONETOME M00535190 3519 manufactured by Boston Scientific Corporation.

Event Text Entries

[142128959] (b)(4). The complainant indicated that the device was 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 report will be filed.
Patient Sequence No: 1, Text Type: N, H10


[142128960] Note: this report pertains to the second of two devices used during the same procedure. It was reported to boston scientific corporation that a stonetome was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019. According to the complainant, during the procedure, when the nurse attempted to bow the device, it was noticed that the cut wire was oriented in the wrong direction which was reportedly pointing at 6 o'clock direction. It remained unusable as the orientation could not be corrected. A second stonetome was used but same thing happened. Reportedly, there was no tortuous anatomy impacting scope positioning and no visible damage to the devices prior to putting it through the scope or after the issue occurred. The procedure was completed with the different 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 Number3005099803-2019-01955
MDR Report Key8519485
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-04-16
Date of Report2019-04-16
Date of Event2019-03-25
Date Mfgr Received2019-03-27
Device Manufacturer Date2018-07-30
Date Added to Maude2019-04-16
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 DE COSTA RICA S.R.L.
Manufacturer Street2546 CALLE PRIMERA PROPARK, COYOL
Manufacturer CityALAJUELA
Manufacturer CountryCS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTONETOME
Generic NameDISLODGER, STONE, BILIARY
Product CodeLQR
Date Received2019-04-16
Model NumberM00535190
Catalog Number3519
Lot Number0022349247
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-16

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