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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 NITINOL CORE GUIDEWIRE, .035", 3 CM, STRAIGHT, STIFF, 150 CM LENGTH; NITINOL GUIDEWIRE
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C.R. BARD, INC. (COVINGTON) -1018233 NITINOL CORE GUIDEWIRE, .035", 3 CM, STRAIGHT, STIFF, 150 CM LENGTH; NITINOL GUIDEWIRE Back to Search Results
Catalog Number 150NSS35
Device Problems Flaked (1246); Material Protrusion/Extrusion (2979)
Patient Problems Exposure to Body Fluids (1745); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/29/2023
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Event Description
It was reported that when the guidewire was used for local anesthesia rigid endoscopic catheterization, the stent was found to be stuck, and when the guidewire was taken out and checked, it was found that the guidewire was barbed, and the guidewire was replaced again, and the barbs still appeared.After the catheterization was placed, the guidewire was replaced, and the situation still occurred, and finally the catheter was successfully placed after the new guidewire was replaced.It prolonged surgery and caused inability to successfully place the catheter.
 
Manufacturer Narrative
The reported event is confirmed manufacturing related.Visual evaluation noted received 3 photo samples.First and third photo sample shows top view of guidewire placed on white paper towel showcasing with guidewire being barbed.Second photo sample shows guidewire sitting on green background with slight indents of present on the guidewire.Based on photo samples received product does not meet specifications.Although an exact root cause could not be determined a potential root cause could be error of inspector.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labelling review is not required as labelling would not have prevented the reported event.Section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
 
Event Description
It was reported that when the guidewire was used for local anesthesia rigid endoscopic catheterization, the stent was found to be stuck, and when the guidewire was taken out and checked, it was found that the guidewire was barbed, and the guidewire was replaced again, and the barbs still appeared.After the catheterization was placed, the guidewire was replaced, and the situation still occurred, and finally the catheter was successfully placed after the new guidewire was replaced.It prolonged surgery and caused inability to successfully place the catheter.The user has been exposed to harmful substances, blood, or bodily fluids.
 
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Brand Name
NITINOL CORE GUIDEWIRE, .035", 3 CM, STRAIGHT, STIFF, 150 CM LENGTH
Type of Device
NITINOL GUIDEWIRE
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer (Section G)
C.R. BARD INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer Contact
xeeroy rada
8195 industrial blvd
covington 30014
7707846100
MDR Report Key18356383
MDR Text Key330889094
Report Number1018233-2023-09054
Device Sequence Number1
Product Code EZB
UDI-Device Identifier00801741051524
UDI-Public(01)00801741051524
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number150NSS35
Device Lot NumberNGHS0847
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/15/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2023
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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