MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2003-11-07 for NONE VIK9S5 NA manufactured by Vitatron Medical B.v..
[423399]
Right innominate vein damaged by tip portion of introducer. Hemothorax and subsequent death followed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000095-2003-00003 |
| MDR Report Key | 630569 |
| Report Source | 01,05 |
| Date Received | 2003-11-07 |
| Date of Event | 2003-07-08 |
| Date Facility Aware | 2003-07-08 |
| Date Mfgr Received | 2003-09-15 |
| Date Added to Maude | 2005-08-30 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NI |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NONE |
| Generic Name | PERMANENT LEAD INTRODUCER |
| Product Code | DTF |
| Date Received | 2003-11-07 |
| Model Number | VIK9S5 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 0 DAY |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 620169 |
| Manufacturer | VITATRON MEDICAL B.V. |
| Manufacturer Address | P.O. BOX 76 6950 AB DIEREN NL |
| Baseline Brand Name | NA |
| Baseline Generic Name | PERMANENT LEAD INTRODUCER |
| Baseline Model No | VIK9S5 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | PERMANENT LEAD INTRODUCER |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | Y |
| Premarket Approval | K8545 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2003-11-07 |