MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2012-10-12 for PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM 21-1500 manufactured by Smiths Medical Md, Inc..
[21756223]
From clinical trial study organizer; it was reported that the device was implanted in pt for administration of clinical trial drug on (b)(6) 2012. According to report, on (b)(6) the device was non-functional during infusion attempts through the system. The system was surgically explanted on (b)(6) 2012 and a new system was implanted. No permanent adverse effects reported.
Patient Sequence No: 1, Text Type: D, B5
[21890330]
One used portal was returned with an attached catheter measuring? Inches in length. Also returned were two segments of unattached catheter measuring 5 and 8? Inches in length. The attached length of catheter was examined: the distal end was found to have an appearance consistent with having been exposed to a heated instrument (melting noted) as was one end of the 5 inch length. The 5 inch length also had several melt markings along its length, and the distal end was found to have been cut which matched up to the proximal end of the 8 inch length. The 8 inch length was the distal most segment of the catheter. The melt features are typical of explants from this user and are not a defect in the product. Testing of the sections of catheter found that, after the melted shut ends were removed, all were found to be patent and without defect or abnormalities and could both flush and aspirate a solution of water without difficulty. The portal/outlet tubes were found to be patent and without any signs of occlusions, total or partial. Unable to duplicate the customers concern of occlusion. Before device decontamination a large fibrous tissue growth was observed on the strain relief. It was on the exterior of the device and had no effect on the functionality. There was no evidence during investigation to confirm the reported event was caused by intrinsic product defect; no problems could be identified with the returned system.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2012-00471 |
| MDR Report Key | 2796829 |
| Report Source | 00,06 |
| Date Received | 2012-10-12 |
| Date of Report | 2012-10-05 |
| Date of Event | 2012-08-31 |
| Date Facility Aware | 2012-08-31 |
| Report Date | 2012-10-05 |
| Date Reported to FDA | 2012-10-05 |
| Date Mfgr Received | 2012-09-07 |
| Device Manufacturer Date | 2010-12-01 |
| Date Added to Maude | 2012-10-22 |
| 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 |
| Manufacturer G1 | SMITHS MEDICAL MD, INC. |
| Manufacturer Street | 1265 GREY FOX RD. |
| Manufacturer City | ST. PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55112 |
| 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 | 2012-10-12 |
| Returned To Mfg | 2012-09-27 |
| Model Number | 21-1500 |
| Catalog Number | 21-1500 |
| Lot Number | 1882782 |
| ID Number | NA |
| Device Expiration Date | 2015-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 2 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL MD, INC. |
| Manufacturer Address | 1265 GREY FOX RD. ST. PAUL MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-10-12 |