MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-08-29 for SAFESHEATH WORLEY RENAL LVI/75-5-62-07-RE manufactured by Pressure Products, Inc..
[2174676]
While utilizing this sheath during placement of pacing lead into the venous system, the tip of the sheath stretched, but would not slit or cut apart as it is designed to do.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5021989 |
| MDR Report Key | 2234423 |
| Date Received | 2011-08-29 |
| Date of Report | 2011-08-29 |
| Date of Event | 2011-08-10 |
| Date Added to Maude | 2011-09-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAFESHEATH WORLEY RENAL |
| Generic Name | SHEATH |
| Product Code | OFL |
| Date Received | 2011-08-29 |
| Returned To Mfg | 2011-08-10 |
| Catalog Number | LVI/75-5-62-07-RE |
| Lot Number | S34689 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRESSURE PRODUCTS, INC. |
| Manufacturer Address | 1861 N. GAFFEY STREET SUITE B SAN PEDRO CA 90731 US 90731 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-08-29 |