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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC BIWIRE NITINOL HYDROPHILIC WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
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COOK INC BIWIRE NITINOL HYDROPHILIC WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY Back to Search Results
Model Number N/A
Device Problem Flaked (1246)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/01/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Event is still under investigation at this time.
 
Event Description
During a pncl procedure on a patient of unknown age and gender, the biwire coating stripped off as it was scrapped on the access needle.It is unclear if the pieces came out with the needle or if the physician had to retrieve them but the physician confirmed all pieces were retrieved from the patient.As some of the coating clogged the access needle, the physician opened another biwire and access needle to complete the procedure.No harm to the patient and no additional procedures were required due to this occurrence.
 
Manufacturer Narrative
Investigation- a review of the complaint history, device history record and trends was conducted for the purpose of this investigation.No product was returned to assist with the evaluation.It is unclear if the pieces came out with the needle or if the physician had to retrieve them but the physician confirmed all pieces were retrieved from the patient.The history records indicate this product was final inspection tested by the supplier.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.The ifu states "when using wire guide through a metal cannula/needle, use caution as damage may occur to outer coating." it is likely that this event was related to product handling as the coating was likely damaged by the access needle.There is no evidence to suggest the product was not manufactured to current specifications.The risk remains acceptable with inclusion of this event and no additional risk reduction activities are required at this time.
 
Event Description
During a pncl procedure on a patient of unknown age and gender, the biwire coating stripped off as it was scrapped on the access needle.It is unclear if the pieces came out with the needle or if the physician had to retrieve them but the physician confirmed all pieces were retrieved from the patient.As some of the coating clogged the access needle, the physician opened another biwire and access needle to complete the procedure.No harm to the patient and no additional procedures were required due to this occurrence.
 
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Brand Name
BIWIRE NITINOL HYDROPHILIC WIRE GUIDE
Type of Device
OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
rita harden
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key5273367
MDR Text Key32888326
Report Number1820334-2015-00849
Device Sequence Number1
Product Code OCY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082536
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/01/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberBWS-038150
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/01/2015
Device Age27 MO
Event Location Hospital
Date Manufacturer Received12/03/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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