MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2004-02-19 for 3.5F BETA-RAIL DELIVERY CATHETER ABR 6001 manufactured by Novoste Corp..
[334836]
The user had difficulty advancing the catheter and removed it, used a cutting balloon to dilate again. The cba was damaged. The catheter was reinserted which was difficult but successful. After successful vbt procedure, while pulling back the catheter the catheter stuck on the guidewire and the user pulled both out. User was not sure which device caused a proximal dissection which remained untreated as it was not significant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1062385-2004-00004 |
| MDR Report Key | 526081 |
| Report Source | 05,07 |
| Date Received | 2004-02-19 |
| Date of Report | 2004-02-19 |
| Date of Event | 2004-01-28 |
| Date Mfgr Received | 2004-01-28 |
| Date Added to Maude | 2004-05-24 |
| 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 | ADAM LOWE, VP |
| Manufacturer Street | 3890 STEFE REYNOLDS BLVD. |
| Manufacturer City | NORCROSS GA 30093 |
| Manufacturer Country | US |
| Manufacturer Postal | 30093 |
| Manufacturer Phone | 7707170904 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3.5F BETA-RAIL DELIVERY CATHETER |
| Generic Name | CATHETER |
| Product Code | MOU |
| Date Received | 2004-02-19 |
| Returned To Mfg | 2004-02-15 |
| Model Number | NA |
| Catalog Number | ABR 6001 |
| Lot Number | 657077 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 515229 |
| Manufacturer | NOVOSTE CORP. |
| Manufacturer Address | 3890 STEVE REYNOLDS BLVD. NORCROSS GA 30093 US |
| Baseline Brand Name | 3.5F BETA-RAIL DELIVERY CATHETER |
| Baseline Generic Name | CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | ABR 6001 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-02-19 |