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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. WHOLEY WIRE; WIRE, GUIDE, CATHETER
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MEDTRONIC, INC. WHOLEY WIRE; WIRE, GUIDE, CATHETER Back to Search Results
Catalog Number WWIJ35260
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code Patient Problem/Medical Problem (2688)
Date of Event 08/07/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
Physician was attempting to use a non-mdt 6fr 135cm thrombectomy catheter with a wholey guidewire.It was reported that there was difficulty advancing the catheter.Physician attempted to remove the catheter with some resistance.Upon removal, the catheter appeared to unravel leaving a portion of the catheter in the lower extremity (below the knee).Multiple unsuccessful attempts were made to retrieve it.The procedure was then aborted with foreign body remaining in the patient.
 
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Brand Name
WHOLEY WIRE
Common Device Name
WIRE, GUIDE, CATHETER
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
MDR Report Key7902677
Report Number2182208-2018-01732
Device Sequence Number16185444
Product Code DQX
UDI-Device Identifier00821684065938
UDI-Public00821684065938
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K120863
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 09/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date06/01/2020
Device Catalogue NumberWWIJ35260
Device Lot Number10859837
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/27/2018
Initial Report FDA Received Date09/24/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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