HYDRA JAGWIRE GUIDEWIRE M00556051 5605

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,07 report with the FDA on 2009-02-25 for HYDRA JAGWIRE GUIDEWIRE M00556051 5605 manufactured by Boston Scientific Corporation- Marlborough.

Event Text Entries

[1004919] A hydra jagwire guidewire was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure (patient age, gender, weight unknown) in 2007. According to the complainant, during the procedure the physician notice that the "jagtip wire was missing", he completed the procedure using only the dream tip of the wire. After the procedure, the physician tried to locate the missing coating tip, but was unable to find it in the patient and thought that may be the coating was missing during unpacking. The procedure was completed with the same hydra jagwire guide device no patient complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


[8153565] No impact or consequences to the patient - component, detachment an evaluation of the suspected device revealed that the jag end of the guidewire had detached due to torsional overload and the fracture site exhibited no deformities or material reduction. Also the fracture surface exhibited elongated dimpled ruptures in a torsional direction. The corewire was sent to the analytical lab to the determine if the fracture had occurred and the cause of it. The analysis revealed that the fracture surface exhibited elongated dimpled ruptures in a torsional direction. No other material anomalies were noted. During the manufacturing procedures the units are inspected 100% at several stations along the production line, verifying the presence of the jag end and its integrity. Units that do not comply with these criteria are rejected. All units are packaged appropriately in order to protect the device from external damage during shipment. A review of the manufacturing record for this particular batch shows that the device met its material, assembly and product specifications at the time of its release to distribution and found no nmrb's (non conforming material review) that could be related to the reported failure. The root cause for this reported issue has been determined as handling damage.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005099803-2008-02714
MDR Report Key1324905
Report Source00,01,05,07
Date Received2009-02-25
Date of Report2007-05-29
Date of Event2007-05-29
Date Mfgr Received2007-05-29
Device Manufacturer Date2007-02-08
Date Added to Maude2009-02-25
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 ContactMR. KEN HIRAKAWA
Manufacturer Street100 BOSTON SCIENTIFIC WAY
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5086836264
Manufacturer G1BOSTON SCIENTIFIC CORPORATION-MIAMI
Manufacturer Street8600 N.W. 41ST STREET
Manufacturer CityMIAMI FL 33166620
Manufacturer CountryUS
Manufacturer Postal Code33166 6202
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHYDRA JAGWIRE GUIDEWIRE
Generic NameFDE
Product CodeFDE
Date Received2009-02-25
Returned To Mfg2007-06-13
Model NumberM00556051
Catalog Number5605
Lot Number0009395119
Device Expiration Date2010-02-06
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION- MARLBOROUGH
Manufacturer Address100 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752


Patients

Patient NumberTreatmentOutcomeDate
10 2009-02-25

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