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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CATH TEMPO 5F PIG 100CM 5SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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CATH TEMPO 5F PIG 100CM 5SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number 451503H5
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/24/2020
Event Type  malfunction  
Manufacturer Narrative
Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
During prep, a 5f 100cm pigtail (pig) 5 side holes (sh) tempo catheter tip was contaminated.There were difficulties removing the product from the packaging.The packaging did not remove.There was no reported patient injury.Another tempo catheter was used to complete the procedure.The target lesion is the carotid artery with no tortuosity, calcification, and twenty percent stenosis.The device was handled according to the instruction for use (ifu).There were no damages to the device packaging.The device will be returned for evaluation.No other information was provided.
 
Manufacturer Narrative
During prep, a 5f 100cm pigtail (pig) 5 side holes (sh) tempo catheter tip was contaminated.There were difficulties removing the product from the packaging.The packaging did not remove.Another tempo catheter was used to complete the procedure.The target lesion is the carotid artery with no tortuosity, calcification, and twenty percent stenosis.The device was handled according to the instruction for use (ifu).There were no damages to the device packaging.No other information was provided.There was no reported patient injury.The device was returned for analysis.One non-sterile unit of a tempo diagnostic catheter (cath tempo 5f pig 100cm 5sh) was received for analysis.The original packaging was not returned.Per visual analysis, three kinks were observed on the catheter body/shaft approximately at 15.8 cm, 45.3 cm and 72.9 cm from the strain relief.No foreign material was observed on the unit.No other anomalies were observed on the unit.Per functional analysis, the flushing test was performed successfully.Neither an obstruction nor a foreign material was observed coming out of the device.Per dimensional analysis, the outer diameter and inner diameter of the body/shaft of the catheter were measured near every kink and the results were found within specification.A product history record (phr) review of lot 17770447 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿packaging/pouch/box - removal difficulty¿ was not confirmed since the original packaging was not returned with the unit.The reported ¿catheter (body/shaft) - foreign material - during prep¿ was not confirmed since no foreign material was observed on the unit.Flushing test was performed on the unit and no foreign material was observed coming out of the unit.Dimensional test near every observed kink was performed and results were observed within specification.However, the exact cause of the kinked areas on the unit could not be conclusively determined during the analysis.Storage/handling factors may have led to the reported event.Per the instructions for use (ifu), which is not intended as a mitigation of risk, ¿do not expose to organic solvents.Store in a cool, dark, dry place.Do not use if package is open or damaged.Do not use the catheter if the ¿use by¿ date on the package label has expired.Do not resterilize.Exposure to temperatures above 54oc (130of) may damage the catheter.¿ neither the phr review, product analysis, nor the information available suggests a design or manufacturing related cause for the reported events therefore, no corrective/preventive action will be taken at this time.
 
Manufacturer Narrative
This device was received for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
 
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Brand Name
CATH TEMPO 5F PIG 100CM 5SH
Type of Device
CATHETER, INTRAVASCULAR, DIAGNOSTIC
MDR Report Key10744626
MDR Text Key213457376
Report Number9616099-2020-04019
Device Sequence Number1
Product Code DQO
UDI-Device Identifier10705032008273
UDI-Public10705032008273
Combination Product (y/n)N
PMA/PMN Number
K973401
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 12/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2021
Device Model Number451503H5
Device Catalogue Number451503H5
Device Lot Number17770447
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/10/2020
Initial Date Manufacturer Received 09/29/2020
Initial Date FDA Received10/27/2020
Supplement Dates Manufacturer Received11/10/2020
12/03/2020
Supplement Dates FDA Received12/07/2020
12/09/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/06/2018
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 Weight56
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