MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-10-26 for DLP PERICARDIAL SUMP 12010 manufactured by Perfusion Systems.
[125096174]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[125096175]
Medtronic received information that during use, the customer reported the pericardial 12010 sump got caught in the patient's mitral valve chords. The product was replaced. The customer stated they were unable to retrieve all parts of the cannula from the patient.
Patient Sequence No: 1, Text Type: D, B5
[129241145]
The physician stated because they used the sump incorrectly as an intracardiac sump, the metal tips got stuck in the mitral chords. They had to cut off the tip off the 12010 sump during the procedure. A small metal coil stuck remained in the mitral chords that could not be removed. Product analysis shows the tip has been cut from the device and the metal tip is separated from the removed section. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184009-2018-00034 |
| MDR Report Key | 8008494 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-26 |
| Date of Report | 2018-12-04 |
| Date of Event | 2018-09-21 |
| Date Mfgr Received | 2018-11-08 |
| Date Added to Maude | 2018-10-26 |
| 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 | PHYSICIAN ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | PERFUSION SYSTEMS |
| Manufacturer Street | 7611 NORTHLAND DR |
| Manufacturer City | BROOKLYN PARK MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55428 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DLP PERICARDIAL SUMP |
| Generic Name | SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS |
| Product Code | DTS |
| Date Received | 2018-10-26 |
| Returned To Mfg | 2018-11-08 |
| Model Number | 12010 |
| Catalog Number | 12010 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR BROOKLYN PARK MN 55428 US 55428 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-26 |