MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-12-05 for VENTR. TUNNEL.PRESS.KIT NL950-V manufactured by Integra Neuro Sciences.
[783867]
It was reported that johnson city pediatric tried to insert an im3. St and a ventrix catheter in a young child. The licox bolt allowed the cc1. Sb and c8b to go into the im3 easily. When the ventrix was added to the icp lumen, it would not go down the lumen even with turning and they could not thread the catheter. The doctor made the decision to remove the entire system and discard as it was covered in blood, and replaced in the same hole with a new licox and ventrix catheter. The replacement worked fine; however, patient is not doing well.
Patient Sequence No: 1, Text Type: D, B5
[7897076]
The device involve in the reported incident is not available for return and evaluation. An investigation has been initiated based on the reported information. See scanned page.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2023988-2007-00073 |
| MDR Report Key | 960193 |
| Report Source | 06 |
| Date Received | 2007-12-05 |
| Date of Report | 2007-12-05 |
| Date Mfgr Received | 2007-11-07 |
| Date Added to Maude | 2007-12-12 |
| 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 | LINDA GOODSTEIN |
| Manufacturer Street | 311C ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08356 |
| Manufacturer Country | US |
| Manufacturer Postal | 08356 |
| Manufacturer Phone | 6099362269 |
| Manufacturer G1 | INTEGRA NEURO SCIENCES |
| Manufacturer Street | 5955 PACIFIC CENTER BLVD. |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENTR. TUNNEL.PRESS.KIT |
| Generic Name | NONE |
| Product Code | HCA |
| Date Received | 2007-12-05 |
| Catalog Number | NL950-V |
| Lot Number | 121202G |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 932106 |
| Manufacturer | INTEGRA NEURO SCIENCES |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-12-05 |