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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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COVIDIEN MFG SOLUTIONS S.A. MAHURKAR CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 8813793013
Device Problem Break (1069)
Patient Problem Unintended Radiation Exposure (4565)
Event Date 05/25/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during the removal of the guide wire after passage of the catheter, the guide wire broke into two (guide wire was unwound). The catheter was not repaired and there was no leak. Alcoholic chlorhexhydrin degerant was used as the cleaning agent on the device and was also used at the insertion site prior to product placement. There was no excessive force used to pull/remove the product and there was nothing unusual observed on the device before use. Before the breakage, there were no abnormal conditions noted. Flushing was done which had a normal result. There were no other products utilized with the device and no other defects/damages found on the product. The guide wire used was the one included in the kit. There were no tools used when they tried to remove the guide wire. An x-ray machine was used to check for retained parts. All parts were recovered. The product had to be replaced with a new one to resolve the issue and the procedure was completed. There was no blood loss and no intervention/treatment was required as a result of the event. It did not lead to or prolonged the patient's hospitalization.
 
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Brand NameMAHURKAR
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
CS 20101
Manufacturer (Section G)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
CS 20101
Manufacturer Contact
avi kluger
5920 longbow drive
boulder, CO 80301
3035306582
MDR Report Key12089926
MDR Text Key259137916
Report Number3009211636-2021-00152
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K943349
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/30/2021
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? Yes
Device Operator
Device Model Number8813793013
Device Catalogue Number8813793013
Device Lot Number1801000112
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/13/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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