MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-02-12 for MIKRO-CATH CARDIOVASCULAR CATHETER 825-0101 manufactured by Millar, Inc..
[4287301]
A user facility was using a series of medical devices during a clinical trial. Two hours after the catheterization procedure, the patient had a stroke. The user facility stated that the mikro-cath performed as indicated during the procedure. The device was discarded after the procedure, as there was no indication that there was a problem with the procedure.
Patient Sequence No: 1, Text Type: D, B5
[11631285]
Two hours after a catheterization procedure, the patient suffered a stroke. The user facility stated that the mikro-cath performed as indicated during the procedure. The device was discarded as there was no indication that there was a problem with the procedure. The patient was part of a clinical trial. There were other devices and drugs used during the procedure. As stated above, the millar inc. Catheter was used and performed as indicated. The user facility stated they had no issues with the mikro-cath catheter. The device was discarded after use as there was no indication of any problem with the catheter. This report is being filed because our device was used during the procedure, but is not suspected to have caused the medical issue. The procedure took place as part of a clinical trial. Multiple devices and drugs were used during the procedure. The device was not returned by the user facility, therefore, no further investigation of the device can be performed. The user facility stated the device performed as indicated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1625382-2014-00001 |
| MDR Report Key | 3650156 |
| Report Source | 05,07 |
| Date Received | 2014-02-12 |
| Date of Report | 2014-02-11 |
| Date of Event | 2014-01-17 |
| Date Mfgr Received | 2014-01-17 |
| Device Manufacturer Date | 2013-06-01 |
| Date Added to Maude | 2014-02-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 6001 GULF FREEWAY |
| Manufacturer City | HOUSTON TX 77021 |
| Manufacturer Country | US |
| Manufacturer Postal | 77021 |
| Manufacturer Phone | 8326677100 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIKRO-CATH CARDIOVASCULAR CATHETER |
| Generic Name | CATHETER, PRESSURE MONITORING CARDIAC |
| Product Code | OBI |
| Date Received | 2014-02-12 |
| Model Number | MIKRO-CATH |
| Catalog Number | 825-0101 |
| Device Expiration Date | 2015-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MILLAR, INC. |
| Manufacturer Address | HOUSTON TX 77021 US 77021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-02-12 |