MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07,company representative, report with the FDA on 2014-12-19 for DLP PERICARDIAL/INTRACARDIAC SUMPS 12112 manufactured by Medtronic Perfusion Systems.
[5200793]
Medtronic received information indicating that during the use of this cannula, the cannula perforated the back of the patient? S heart. A second pump run was required to resolve the event. The surgeon was using this cannula as a substitute due to the unavailability of the surgeon? S normal cannula. The surgeon stated that this cannula was more rigid, which resulted in the perforation. The cannula was discarded by the customer and will not be returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[12671548]
The device was discarded by the customer and will not be returned to medtronic for evaluation. Without the return of the product, no definitive conclusion can be made regarding the clinical observation. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[101847883]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184009-2014-00097 |
| MDR Report Key | 4346786 |
| Report Source | 05,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-12-19 |
| Date of Report | 2014-11-21 |
| Date of Event | 2014-11-21 |
| Date Mfgr Received | 2014-11-21 |
| Date Added to Maude | 2014-12-19 |
| 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 |
| 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 | MEDTRONIC STRUCTURAL HEART |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW 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 | DLP PERICARDIAL/INTRACARDIAC SUMPS |
| Generic Name | SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS |
| Product Code | DTS |
| Date Received | 2014-12-19 |
| Model Number | 12112 |
| Catalog Number | 12112 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DRIVE MINNEAPOLIS MN 55428 US 55428 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2014-12-19 |