MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,s report with the FDA on 2015-09-09 for PORT-A-CATH II INTRASPINAL ACCESS SYSTEM 21-1500-22 manufactured by Smiths Medical.
[25290111]
(b)(4) i was hoping for a code that would capture the necesity of surgically removing a port-a-cath (not due to twiddlers syndrome- just in general). Additionally, i wanted to capture the fact that general anesthesia was administered to the patient (not patchy anesthesia- just the necesity of general anesthesia). Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
[25290112]
From clinical trial study organizer: it was reported that the device was implanted in patient for administration of clinical trial drug on (b)(6) 2012. According to reporter, the device had to be surgically explanted from patient on an unscheduled basis on (b)(6) 2015. Clinical trial study organizer reported that the access system was replaced with another system after explant. Additional information has been requested on the reason for the explant and not received at this time. No permanent adverse effects reported
Patient Sequence No: 1, Text Type: D, B5
[49815747]
One used intraspinal portal with a 16 inch length of attached catheter was returned for evaluation. The outlet tube was examined and found to have broken away from itself from within the outlet tube supporter chamber. The examination of the break surface showed that the welded joints of the outlet tube were still intact; the surface of the break at the outlet tube supporter area was found to be consistent with stress fatigue fracture. The fracture of the outlet tube determined to likely have been caused by excessive flexing of the outlet tubing which the device was not intended for. It is reported that the customer is using this device in a situation that is new for the product. There was no evidence found to suggest the event was caused from an intrinsic defect in the product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2015-00652 |
| MDR Report Key | 5064707 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,S |
| Date Received | 2015-09-09 |
| Date of Report | 2015-09-09 |
| Date of Event | 2015-08-17 |
| Date Mfgr Received | 2015-08-21 |
| Date Added to Maude | 2015-09-09 |
| 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 | MS. MICHELE SELIGA |
| Manufacturer Street | 1265 GREY FOX RD. |
| Manufacturer City | ST. PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7633833052 |
| Manufacturer G1 | SMITHS MEDICAL ASD INC., |
| Manufacturer Street | 1265 GREY FOX ROAD |
| 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 ACCESS SYSTEM |
| Generic Name | PORT/CATHETER, INTERNAL SUBCUTANEOUS |
| Product Code | LNY |
| Date Received | 2015-09-09 |
| Model Number | NA |
| Catalog Number | 21-1500-22 |
| Lot Number | ASKU |
| 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 |
| Manufacturer Address | 1265 GREY FOX ROAD ST. PAUL MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-09-09 |