MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,06 report with the FDA on 2012-03-31 for PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM 21-1500 manufactured by Smiths Medical Md.
[2530252]
Device was implanted in pt to allow for administration of a clinical trial drug on (b)(6) 2012. On (b)(6), the pt reported to treatment site for scheduled dose of clinical trial drug. The device could be accessed but no cerebrospinal fluid could be drawn through the system. On (b)(6), the pt received dose of clinical trial drug administered via lumbar puncture. On (b)(6), surgical exploration was performed which showed the catheter portion of the device had fractured in two places. The device was explanted and a new access device was implanted. No permanent adverse effects reported.
Patient Sequence No: 1, Text Type: D, B5
[9954179]
Customer has not yet returned the device to the mfr for device eval. When and if the device becomes available and is returned and evaluated the mfr will file a f/u report detailing the results of the eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2012-00113 |
| MDR Report Key | 2522392 |
| Report Source | 00,01,06 |
| Date Received | 2012-03-31 |
| Date of Report | 2012-03-30 |
| Date of Event | 2012-02-08 |
| Date Facility Aware | 2011-12-29 |
| Report Date | 2012-03-30 |
| Date Reported to FDA | 2012-03-30 |
| Date Mfgr Received | 2012-03-02 |
| Device Manufacturer Date | 2011-05-01 |
| Date Added to Maude | 2012-04-10 |
| 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 | PETE HIRTE |
| Manufacturer Street | 1265 GREY FOX RD. |
| Manufacturer City | ST. PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6516287384 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM |
| Generic Name | LNY CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL |
| Product Code | LNY |
| Date Received | 2012-03-31 |
| Model Number | 21-1500 |
| Catalog Number | 21-1500 |
| Lot Number | 2006077 |
| ID Number | NA |
| Device Expiration Date | 2016-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL MD |
| Manufacturer Address | ST. PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-03-31 |