MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2004-01-05 for PORT VAXCEI PASV 45-215 manufactured by Boston Scientific.
[357995]
It was reported that four weeks after a therapeutic vaxcel port implantation, the catheter separated from the port and then migrated to the right atrium. The fragments have since been removed. This device has not been received for evaluation yet. Therefore, a failure analysis is not available and company is unable to determine if the device met its specifications. Should further details become avaiable, a supplemental medwatch report will be filed under the appropriates sequence number. Company is unable to determine the relationship between the device and the cause for this event. The directions for use outline appropriate placement, access and maintenance procedures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000001-2003-00091 |
| MDR Report Key | 504203 |
| Report Source | 05,06 |
| Date Received | 2004-01-05 |
| Date of Report | 2003-11-17 |
| Date Added to Maude | 2004-01-06 |
| 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 | 3 |
| Manufacturer Contact | NANCY CUTINO |
| Manufacturer Street | ONE BOSTON SCIENTIFIC PLACE |
| Manufacturer City | NATICK MA 01760135 |
| Manufacturer Country | US |
| Manufacturer Postal | 01760135 |
| Manufacturer Phone | 5086525066 |
| Manufacturer G1 | BOSTON SCIENTIFIC |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORT VAXCEI PASV |
| Generic Name | PORT |
| Product Code | LKG |
| Date Received | 2004-01-05 |
| Model Number | NA |
| Catalog Number | 45-215 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 492995 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | 10 GLENS FALLS TECHNICAL PARK GLENS FALLS NY 12801 US |
| Baseline Brand Name | PORT VAXCEI PASV |
| Baseline Generic Name | PORT |
| Baseline Model No | NA |
| Baseline Catalog No | 45-215 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-01-05 |