MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05,06 report with the FDA on 2014-06-20 for PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM 21-1500 manufactured by Smiths Medical Inc..
[19798512]
From clinical trial study organizer: it was reported that the device was in use with a pt for infusion on idursulfase-it (10mg monthly). The device was implanted on (b)(6)-2012 and treatment commenced (b)(6) 2012. After two years in use, the final dose was given to the pt (b)(6) 2014. The device was removed from the pt (b)(6)-2014; the user facility reported to observe a break in the catheter near the portal connection. It is unk if the issue was identified prior to, or after, device removal. Further info has been requested, but none has been received at this time. No adverse effects to the pt were reported.
Patient Sequence No: 1, Text Type: D, B5
[19913529]
Mfr completed entire form. 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 follow up report detailing the results of the eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2014-00424 |
| MDR Report Key | 3901525 |
| Report Source | 00,01,05,06 |
| Date Received | 2014-06-20 |
| Date of Report | 2014-06-20 |
| Date of Event | 2014-05-19 |
| Date Facility Aware | 2014-05-19 |
| Report Date | 2014-06-20 |
| Date Reported to FDA | 2014-06-20 |
| Date Mfgr Received | 2014-05-22 |
| Device Manufacturer Date | 2011-05-01 |
| Date Added to Maude | 2014-07-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL |
| Product Code | LNY |
| Date Received | 2014-06-20 |
| 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 | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL INC. |
| Manufacturer Address | ST. PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2014-06-20 |