CODMAN * 63-4031

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-08-02 for CODMAN * 63-4031 manufactured by Codman And Shurtleff, Inc..

Event Text Entries

[710796] From the operative report: (procedure was stripping greater saphenous vein. ) "we then began to strip. There was no difficulty until we got to the mid calf where the large cluster of varicosities was. We had some difficulty getting the stripper through that area and upon steady consistent pulling, the stripper wire came out without the stripper head. The stripper head appeared to have pulled the tip of the stripper wire off and the wire came out. This was a malfunction of this instrument. We could easily palpate the stripper head because of its size and superficial nature and therefore, we cut down over that in two areas over the large cluster of veins, and in the process of identifying and retrieving the stripper head as well as the small cap that was torn off of the stripper wire, we dealt with many of the varicosities that were in this clump and we were able to avulse and strip these. We found the long saphenous vein that had been stripped at that point. We then also removed the kerlix gauze intact. Upon completing that, we did carry out four extra stabs in the more posterior portion of the leg to complete the phlebectomy. This was assisted with a small crochet hook for disrupting the tributaries in the posterior calf region. We then stripped the remainder of the vein from the ankle to the mid calf with a small stripper head and there was no difficulty with that. At that point, the groin was closed in the deep layer with 3-0 vicryl and the skin was closed using 4-0 monocryl. The two small incisions made in the medial calf to retrieve the stripper head were also closed with 4-0 monocryl in a running subcuticular fashion. The ankle incision was also closed using 4-0 monocryl in a running subcuticular fashion. The remaining stabs were not closed. The leg was cleansed with hydrogen peroxide and saline. Dry dressings were applied to the groin, the two medial calf incisions and the calf incision. Telfa and gauze were applied to the stabs and the leg was wrapped with an ace bandage. The patient tolerated the procedure well and was transferred to the recovery room in stable condition. There should be no long-term sequelae to this, as the entire instrument was removed, albeit requiring two extra small incisions in the medial calf. The stripper will be sent out for company analysis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number903492
MDR Report Key903492
Date Received2007-08-02
Date of Report2007-08-02
Date of Event2007-07-26
Report Date2007-08-02
Date Reported to FDA2007-08-02
Date Added to Maude2007-08-29
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameCODMAN
Generic NameVEIN STRIPPER
Product CodeGAJ
Date Received2007-08-02
Model Number*
Catalog Number63-4031
Lot NumberJY639
ID Number*
Device AvailabilityN
Device Age1 DY
Implant FlagY
Date RemovedV
Device Sequence No1
Device Event Key878718
ManufacturerCODMAN AND SHURTLEFF, INC.
Manufacturer Address325 PARAMOUNT DRIVE RAYNHAM MA 02767 US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2007-08-02

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