MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-08-05 for SHEATH INTRODUCER KIT 6.0 FR. AK-6-054-1 manufactured by Arrow International.
[3038]
Introducer 6. 0 fr. Had a crack at insertion hubinvalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: yes. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4899 |
| MDR Report Key | 4899 |
| Date Received | 1992-08-05 |
| Date of Report | 1992-08-05 |
| Date of Event | 1992-04-01 |
| Report Date | 1992-08-05 |
| Date Added to Maude | 1993-06-10 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHEATH INTRODUCER KIT 6.0 FR. |
| Product Code | EYT |
| Date Received | 1992-08-05 |
| Model Number | AK-6-054-1 |
| Device Availability | * |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 4605 |
| Manufacturer | ARROW INTERNATIONAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-08-05 |