MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-04-15 for NEO MAPCATH SENSOR STYLET 0.8FR 60-2008 manufactured by Corpak Medsystems.
[3349801]
Event description: the stylet used in advancing the picc line broke while inside the pt and became an intravascular foreign body. The piece required surgical intervention (cardiac catheterization) for removal. The "piece" was removed without incident. According to the customer, the stylet was inserted into the picc prior to insertion. There was no reported resistance upon insertion or removal. The picc line was shortened prior to placing stylet. According to the customer, the picc was not flushed prior to stylet removal.
Patient Sequence No: 1, Text Type: D, B5
[10779803]
There was no report of pt injury. The actual sample has not been returned. Samples from the same lot were tested at greater than 17n which is greater than any force expected in the clinical setting. No mfg or design defect was identified in the investigation. The clinician did not report any difficulties with stylet insertion or picc placement.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009124963-2013-00011 |
| MDR Report Key | 3075015 |
| Report Source | 05,06 |
| Date Received | 2013-04-15 |
| Date of Report | 2013-04-09 |
| Date of Event | 2013-02-05 |
| Date Mfgr Received | 2013-03-22 |
| Device Manufacturer Date | 2011-05-01 |
| Date Added to Maude | 2013-04-30 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1001 ASBURY DR |
| Manufacturer City | BUFFALO GROVE IL 60089 |
| Manufacturer Country | US |
| Manufacturer Postal | 60089 |
| Manufacturer Phone | 8474033400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEO MAPCATH SENSOR STYLET |
| Generic Name | NAVIGATOR WIRE |
| Product Code | OMF |
| Date Received | 2013-04-15 |
| Model Number | 0.8FR |
| Catalog Number | 60-2008 |
| Lot Number | 4427 |
| Device Expiration Date | 2016-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORPAK MEDSYSTEMS |
| Manufacturer Address | 1001 ASBURY DR BUFFALO GROVE IL 60089 US 60089 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2013-04-15 |