MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-03-18 for NEO MAPCATH SENSOR STYLET 0.8FR 60-2008 manufactured by Corpak Medsystems.
[21754917]
The stylet used in advancing the picc line broke into two pieces while inside the patient and became intravascular foreign bodies. Each piece required surgical intervention (cardiac catheterization) for removal. According to the customer the stylet was inserted into the picc prior to insertion. The picc was also shortened as part of the procedure. The position of the picc was not verified by the navigator signal but by x-ray. Per xray it was found that one piece was in the heart while the other was in the liver. Both were successfully removed without incident.
Patient Sequence No: 1, Text Type: D, B5
[21893688]
There was no report of patient 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 manufacturing or design defect was identified in the investigation. The customer indicated that the stylet was not tested for signal integrity and there was no clear signal during the procedure. It was also reported that the picc line was cut to shorten the length. All of these steps may have contributed to this failure mode.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009124963-2013-00009 |
| MDR Report Key | 3037276 |
| Report Source | 05,06 |
| Date Received | 2013-03-18 |
| Date of Report | 2013-03-18 |
| Date of Event | 2013-02-05 |
| Date Mfgr Received | 2013-02-25 |
| Device Manufacturer Date | 2011-05-01 |
| Date Added to Maude | 2013-04-19 |
| 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 | NONE |
| Product Code | OMF |
| Date Received | 2013-03-18 |
| Model Number | 0.8FR |
| Catalog Number | 60-2008 |
| Lot Number | 4488 |
| 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 | 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 | 2013-03-18 |