MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2009-07-29 for HEMEDEX QFLOW 500 PROBE H0000-1600 manufactured by Hemedex.
[17865980]
Background: a male patient aged (b)(6) with traumatic brain injury required emergency left frontoparietal decompressive craniotomy ((b)(6) 2009), in which a large craniotomy was carried out, the bone flap was not replaced and the dura was left open. Four monitoring devices were inserted during the procedure. Adverse event ((b)(6) 2009: 11. 00 pm) microdialysis and icp catheters were removed uneventfully. However, extra traction had to be applied to the hemedex catheter, which was seen to be missing its distal portion (length undetermined at this stage) on removal. When the adtech strip was removed, it was seen to be partially transacted at the base of the flanged part of the strip, and one platinum contact was missing. The adtech strip and microdialysis catheter were retained, but not the icp probe or hemedex probe. Ct scan showed the remaining portion of the hemedex probe in the subgaleal plane, entirely outside and posterior to the craniotomy margin, and hence some 2 cm from the nearest brain tissue.
Patient Sequence No: 1, Text Type: D, B5
[17917863]
The device was not returned to the manufacturer. The user facility did however make conclusions as to the cause of the failure. Their conclusions were that hemedex and ecog leads became crossed during removal, the hemedex lead partially dividing the ecog connection at the base of the flange, and itself became severed at this point by entrapment in the ecog strip flange. This is the first such incident at the user facility, in an experience of some 80 cases in which one or more microdialysis/licox/icp/hemedex probes have been placed near an adtech ecog strip. Records at hemedex show that in over 3,500 uses of the probe, no events similar to this have been reported. Evaluation concludes this to be an isolated event attributed to user handling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003730855-2009-00001 |
| MDR Report Key | 1424322 |
| Report Source | 01,08 |
| Date Received | 2009-07-29 |
| Date of Report | 2009-07-24 |
| Date of Event | 2009-06-28 |
| Date Mfgr Received | 2009-06-30 |
| Device Manufacturer Date | 2008-05-01 |
| Date Added to Maude | 2011-03-30 |
| 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 Contact | DEAN HONKONEN |
| Manufacturer Street | 222 THIRD STREET SUITE T123 |
| Manufacturer City | CAMBRIDGE MA 02142 |
| Manufacturer Country | US |
| Manufacturer Postal | 02142 |
| Manufacturer Phone | 6175771759 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMEDEX QFLOW 500 PROBE |
| Generic Name | DPW, FLOWMETER, BLOOD, CARDIOVASCULAR |
| Product Code | DPW |
| Date Received | 2009-07-29 |
| Model Number | H0000-1600 |
| Catalog Number | H0000-1600 |
| Lot Number | 0624801 |
| Device Expiration Date | 2011-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEMEDEX |
| Manufacturer Address | 222 THIRD STREET SUITE T123 CAMBRIDGE MA 02142 US 02142 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-07-29 |