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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 M0055658010
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/30/2014
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a jagwire guidewire was used during an endoscopic retrograde cholangiopancreatography procedure performed on (b)(6) 2014.According to the complainant, during the procedure, while inserting the jagwire guidewire into the sphincterotome, the hydrophilic tip was detached inside the patient exposing the tip of the metal corewire.The detached tip was not retrieved.The procedure was not completed due to this event.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
Reported event of guidewire distal tip detached exposing the tip of the metal corewire.The device has not been received for analysis.Upon receipt and 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 examination of the guidewire revealed that the distal tip was detached exposing the tip of the metal corewire approximately 3.6cm.Presence of adhesive remnants were found indicating that the pebax was properly attached to the corewire.No evidence of corewire fractured.The complaint is 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.
 
Event Description
It was reported to boston scientific corporation that a jagwire guidewire was used during an endoscopic retrograde cholangiopancreatography procedure performed on (b)(6) 2014.According to the complainant, during the procedure, while inserting the jagwire guidewire into the sphincterotome, the hydrophilic tip was detached inside the patient exposing the tip of the metal corewire.The detached tip was not retrieved.The procedure was not completed due to this event.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 Key4375333
MDR Text Key5118076
Report Number3005099803-2014-04022
Device Sequence Number1
Product Code OCY
Combination Product (y/n)N
Reporter Country CodeEG
PMA/PMN Number
K141820
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/07/2014
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 Date06/26/2016
Device Model NumberM0055658010
Device Catalogue Number5658-01S
Device Lot Number16203224
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/03/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/16/2015
Initial Date FDA Received12/31/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/09/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/27/2013
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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