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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL, LLC ARROW MULTI-LUMEN CVC KIT CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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ARROW INTERNATIONAL, LLC ARROW MULTI-LUMEN CVC KIT CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number CDC-42703-XP1A
Device Problem Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/29/2021
Event Type  Injury  
Event Description
A right ij triple lumen catheter was inserted in a pt with severe sepsis. At the conclusion of the procedure, it was noted the guidewire was retained within the catheter and partially in the ivc. The catheter was not free-floating and was successfully retrieved by ir. Unfortunately, guidewires have a known design "flow" in that there was no hard-stop design measures, other than the professional user, to prevent a guidewire from 'slipping away' into the catheter itself.
 
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Brand NameARROW MULTI-LUMEN CVC KIT
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
ARROW INTERNATIONAL, LLC
MDR Report Key12099396
MDR Text Key259656590
Report NumberMW5102225
Device Sequence Number1
Product Code FOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 06/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberCDC-42703-XP1A
Device Lot Number23F20K0126
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 06/30/2021 Patient Sequence Number: 1
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