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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 UNK548
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/25/2014
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, the hydrophilic tip detached exposing the tip of the metal corewire.The procedure was completed with this 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
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Reported event of guidewire distal tip detached exposing the tip of the metal corewire.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 examination of the guidewire revealed that the device was returned inside the autotome device.The device had a segment of the distal tip detached inside the autotome injection lumen.The tip of the jagwire could have been stuck inside the incorrect lumen of the autotome and then detached due to manipulation of the device during procedure since there was an inner wall fracture found in the autotome extrusion.There was a fracture in the inner wall of the autotome which indicates issues in polymer filling/cooling incorrect material formation.The complaint is consistent with the return that the distal tip was detached exposing the tip of the metal corewire.The most probable root cause is "caused by other device.".
 
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, the hydrophilic tip detached exposing the tip of the metal corewire.The procedure was completed with this 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 Key4371663
MDR Text Key5112058
Report Number3005099803-2014-04084
Device Sequence Number1
Product Code OCY
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K141820
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/04/2014
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 Model NumberUNK548
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/27/2015
Initial Date FDA Received12/30/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/26/2015
Was Device Evaluated by Manufacturer? Yes
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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