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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) JAGWIRE?; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
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BOSTON SCIENTIFIC - COSTA RICA (COYOL) JAGWIRE?; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY Back to Search Results
Model Number M0055658011
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/28/2014
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a jagwire guidewire was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2014.According to the complainant, during the procedure, the hydrophilic tip of the jagwire guidewire was detached exposing the tip of the metal corewire.No part of the guidewire detached inside the patient.The procedure was completed with a new jagwire guidewire.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 stable.
 
Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over 18 years old.(b)(4).The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Manufacturer Narrative
A visual evaluation of the returned device found the distal tip was peeled, exposing the corewire, approximately 1.4cm.Presence of adhesive remnants were found indicating that the pebax was properly attached to the corewire.No evidence of corewire fractured.The complaint is not consistent with the return that the distal tip was detached exposing the tip of the metal corewire.Based on all gathered information, the most probable root cause is undeterminable.A dhr (device history record) review was performed and no deviation was found.A search of the complaint database confirmed that no similar complaints exist for the specified batch.
 
Event Description
It was reported to boston scientific corporation that a jagwire guidewire was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2014.According to the complainant, during the procedure, the hydrophilic tip of the jagwire guidewire was detached exposing the tip of the metal corewire.No part of the guidewire detached inside the patient.The procedure was completed with a new jagwire guidewire.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 stable.
 
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Brand Name
JAGWIRE?
Type of Device
ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
Manufacturer (Section D)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS 
Manufacturer (Section G)
BOSTON SCIENTIFIC - COSTA RICA (COYOL)
2546 first street
propark free zone
alajuela
CS  
Manufacturer Contact
nancy cutino
100 boston scientific way
marlborough, MA 01752
5086834000
MDR Report Key4355659
MDR Text Key21551688
Report Number3005099803-2014-03927
Device Sequence Number1
Product Code OCY
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K141820
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/28/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/19/2015
Device Model NumberM0055658011
Device Catalogue Number5658-01
Device Lot Number15620942
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/29/2015
Initial Date FDA Received12/23/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/19/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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