MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04,05,06 report with the FDA on 2009-12-31 for NAVILYST MEDICAL 90701062 manufactured by Navilyst Medical.
[14873561]
As reported by the end user in (b)(6), while preparing for a pci procedure, the physician was unable to flush the pressure monitoring line due to an occlusion in the line. The device was set aside to be returned to the mfr for evaluation. The procedure was completed with another of the same device and without further complications. As the reported defect was noted during prep, there was no contact with the pt and hence no harm to the pt.
Patient Sequence No: 1, Text Type: D, B5
[15522298]
The reported defective device has been received for eval. An investigation into the reported event is being conducted. Upon completion of the investigation, a follow-up medwatch will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1317056-2010-00001 |
| MDR Report Key | 1579046 |
| Report Source | 01,04,05,06 |
| Date Received | 2009-12-31 |
| Date of Report | 2009-12-09 |
| Date of Event | 2009-12-07 |
| Date Added to Maude | 2010-08-27 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL DUERR |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal | 12801 |
| Manufacturer Phone | 5187424571 |
| Manufacturer G1 | NAVILYST MEDICAL |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12801 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NAVILYST MEDICAL |
| Generic Name | PRESSURE MONITORING LINE |
| Product Code | DRI |
| Date Received | 2009-12-31 |
| Returned To Mfg | 2009-12-16 |
| Model Number | NA |
| Catalog Number | 90701062 |
| Lot Number | UNK |
| ID Number | PRESSURE MON. LINE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NAVILYST MEDICAL |
| Manufacturer Address | GLENS FALLS NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-31 |