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 |