MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2005-01-20 for Z-MED II X CATHETER 305X PDZ717 manufactured by Numed Canada, Inc..
[19965813]
After procedure, the balloon could not be pulled back into the introducer. The distal part of the balloon was cut off by the physician, and a surgeon removed it antegrade out of the femoral vein. The pt has since recovered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9618000-2004-00008 |
| MDR Report Key | 569935 |
| Report Source | 01,08 |
| Date Received | 2005-01-20 |
| Date of Report | 2005-01-19 |
| Date of Event | 2004-11-24 |
| Date Mfgr Received | 2004-12-07 |
| Device Manufacturer Date | 2003-05-01 |
| Date Added to Maude | 2005-02-04 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | NICHELLE LAFLESH |
| Manufacturer Street | 45 SECOND ST WEST |
| Manufacturer City | CORNWALL, ONTARIO K6J 1G3 |
| Manufacturer Country | CA |
| Manufacturer Postal | K6J 1G3 |
| Manufacturer Phone | 3284491 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | Z-MED II X CATHETER |
| Generic Name | VALVULOPLASTY CATHETER |
| Product Code | MAD |
| Date Received | 2005-01-20 |
| Returned To Mfg | 2005-01-07 |
| Model Number | 305X |
| Catalog Number | PDZ717 |
| Lot Number | JZX-0010 |
| ID Number | * |
| Device Expiration Date | 2008-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 559783 |
| Manufacturer | NUMED CANADA, INC. |
| Manufacturer Address | 45 SECOND ST. CORNWALL, ONTARIO CA K6J 1G3 |
| Baseline Brand Name | Z-MED II X CATHETER |
| Baseline Generic Name | VALVULOPLASTY CATHETER |
| Baseline Model No | 305X |
| Baseline Catalog No | PDZ717 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-01-20 |