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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODMAN & SHURTLEFF CATHETER WITH TAPERED CONNECTOR ARTERIAL CATHETER

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CODMAN & SHURTLEFF CATHETER WITH TAPERED CONNECTOR ARTERIAL CATHETER Back to Search Results
Model Number IP37957
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/15/2020
Event Type  malfunction  
Manufacturer Narrative
Intera is aware that the tapered catheter is being used off-label with the medtronic pump for hepatic artery infusion. The surgical staff disposed of the catheter, so it was unavailable for physical evaluation. The lot used in the surgery was unknown. According to intera sales records, only two lots of catheters were sold to the reporter's institution, lot j32r96 and j58x05. The lot history records for both lots were reviewed and no nonconformances or deviations were noted in the records. No other reports of missing beads/rings have been reported to intera. For reference, the beads/rings are located at the end of the catheter. The surgeon may cut the end of the catheter when prepping for surgery and it may be possible to cut the beads/rings. Since no physical evaluation was able to be performed, it is undetermined if the catheter was cut in a manner that would have cut the bead. Since no other complaints have been reported and no product defect trend is detected, this complaint will be considered closed with no further corrective action. If additional complaint(s) are reported, corrective action will be considered.
 
Event Description
During a hepatic artery infusion implantation surgery, the surgeon reported that the tapered catheter was missing one of the three beads used to suture the catheter in place. The catheter was discarded and another catheter was used in place. There was no impact to the patient reported.
 
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Brand NameCATHETER WITH TAPERED CONNECTOR
Type of DeviceARTERIAL CATHETER
Manufacturer (Section D)
CODMAN & SHURTLEFF
325 paramount drive
rayhnam MA 02767
Manufacturer (Section G)
INTERA ONCOLOGY
65 william street
suite 200
wellesley MA 02481
Manufacturer Contact
sarah lapp
65 william street
suite 200
wellesley, MA 02481
7814895724
MDR Report Key10681146
MDR Text Key240180241
Report Number3015537318-2020-00011
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P890055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 10/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIP37957
Device Catalogue NumberIP37957
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 Received09/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/14/2020 Patient Sequence Number: 1
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