RX LOCKING DEVICE AND BIOPSY CAP M00545260 4526S

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 2019-03-06 for RX LOCKING DEVICE AND BIOPSY CAP M00545260 4526S manufactured by Boston Scientific Corporation.

Event Text Entries

[138001392] (b)(4). According to the complainant, the suspect device has been disposed and is not available for return. If any further relevant information is received, a supplemental mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10


[138001393] It was reported to boston scientific corporation that an rx locking device/biopsy cap was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019. According to the complainant, the sponge in the biopsy cap detached during the procedure. The procedure was still completed using the complaint device. A brush was then used to push out the detached sponge from the scope after the procedure. There was no serious injury nor adverse patient effects reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005099803-2019-01057
MDR Report Key8395756
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-03-06
Date of Report2019-03-06
Date of Event2019-02-06
Date Mfgr Received2019-02-07
Device Manufacturer Date2019-01-18
Date Added to Maude2019-03-06
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 NameRX LOCKING DEVICE AND BIOPSY CAP
Generic NameENDOSCOPE AND/OR ACCESSORIES
Product CodeODC
Date Received2019-03-06
Model NumberM00545260
Catalog Number4526S
Lot Number23204002
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 2019-03-06

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