MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 1998-06-17 for 5 1/2" FEMORAL VEIN CATHETER MCF55 manufactured by Medcomp.
[103892]
The lumen of the catheter broke off inside the pt and had to be surgically removed.
Patient Sequence No: 1, Text Type: D, B5
[16650454]
The initial visual examination of the device under 3x magnification showed that there were signs of a short elongated area on the lumen of the catheter, just distal to the catheter hub. This deformation of the catheter lumen at the point of the break appears to be due to a sharp squeezing force applied to the lumen sidewalls. After the visual examination a test was designed to simulate the possible failure mode on 10 sterilized samples. The catheters were exposed to lodophor pvp solution daily for 10 days. On the 11th day the catheters were conditioned to 37 degrees celsius and a tensile test was performed on the sample catheters. None of the 10 test samples exhibited reduced physical characteristics due to the eio sterilization, lodophor pvp treatment or temperature conditioning. Although the engineering dept was unable to reproduce the failure mode co believes that the failure was consistent with our original observation, a sharp object being compressed against the lumen sidewall in conjunction with opposing distal and proximal force being applied on the catheter lumen. The customer has been sent a copy of the directions for use for the femoral catheter. The directions for use are included in the labeling that goes into this kit. Co is submitting a copy of these directions for use with this final report with the applicabe sections highlighted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2518902-1998-00098 |
| MDR Report Key | 173145 |
| Report Source | 01,08 |
| Date Received | 1998-06-17 |
| Date of Report | 1998-06-17 |
| Date of Event | 1998-05-01 |
| Date Facility Aware | 1998-05-19 |
| Report Date | 1998-06-16 |
| Date Mfgr Received | 1998-05-19 |
| Date Added to Maude | 1998-06-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5 1/2" FEMORAL VEIN CATHETER |
| Generic Name | HEMODIALYSIS CATHETER |
| Product Code | LFK |
| Date Received | 1998-06-17 |
| Model Number | NA |
| Catalog Number | MCF55 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 DAY |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | M |
| Device Sequence No | 1 |
| Device Event Key | 168355 |
| Manufacturer | MEDCOMP |
| Manufacturer Address | 1499 DELP DR. HARLEYSVILLE PA 19438 US |
| Baseline Brand Name | 5 1/2" FEMORAL VEIN CATHETER |
| Baseline Generic Name | FEMORAL VEIN CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | MCF55 |
| Baseline ID | NA |
| Baseline Device Family | MEDCOMP SINGLE LUMEN HEMO-CATH |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K801967 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-06-17 |