MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-31 for MULLINS TRANSSIPTAL SHEATH 008551 manufactured by Unknown.
[2938]
While trying to advance catheter through the sheath, the sheath was noted to be kinked significantly enough to prevent passage. The sheath was removed without any complicatiins. Device was not savedinvalid data - regarding single use labeling of device. Patient medical status prior to event: unknown. There was not 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. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: unknown (cannot determine). Corrective actions: device discarded. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4716 |
| MDR Report Key | 4716 |
| Date Received | 1992-07-31 |
| Date of Report | 1992-07-31 |
| Date of Event | 1992-06-24 |
| Date Facility Aware | 1992-06-24 |
| Report Date | 1992-07-31 |
| Date Reported to FDA | 1992-07-31 |
| Date Reported to Mfgr | 1992-07-31 |
| Date Added to Maude | 1993-06-07 |
| 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 | MULLINS TRANSSIPTAL SHEATH |
| Generic Name | USCF INTRODUCER |
| Product Code | EYT |
| Date Received | 1992-07-31 |
| Catalog Number | 008551 |
| Lot Number | 540122 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | * |
| Implant Flag | * |
| Device Sequence No | 1 |
| Device Event Key | 4432 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-07-31 |