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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 M00556601
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Patient Involvement (2645)
Event Date 11/10/2014
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a jagwire guidewire was inspected on (b)(6) 2014.According to the complainant, the jagwire guidewire was not in the sterile pouch when the box was opened.The product was not used on the patient.
 
Manufacturer Narrative
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 outside the sealed pouch.The complaint was not confirmed since the returned device showed signs of manipulation and it was received outside the hoop.Based on all gathered information, the investigation fails to determine a definite root cause.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 inspected on (b)(6) 2014.According to the complainant, the jagwire guidewire was not in the sterile pouch when the box was opened.The product was not used on the patient.
 
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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 Key4329800
MDR Text Key16179431
Report Number3005099803-2014-03971
Device Sequence Number1
Product Code OCY
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K141820
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 11/18/2014
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 Date08/10/2017
Device Model NumberM00556601
Device Catalogue Number5660
Device Lot Number17191157
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/12/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/09/2015
Initial Date FDA Received12/15/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/02/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/12/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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