Brand Name | DLP FEMORAL ARTERIAL CANNULA |
Type of Device | CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS |
Manufacturer (Section D) |
PERFUSION SYSTEMS |
7611 northland dr |
brooklyn park MN 55428 |
|
Manufacturer (Section G) |
MEDTRONIC STRUCTURAL HEART |
8200 coral sea street ne |
|
mounds view MN 55112 |
|
Manufacturer Contact |
paula
bixby
|
8200 coral sea street ne |
mounds view, MN 55112
|
7635055378
|
|
MDR Report Key | 4888064 |
MDR Text Key | 16990701 |
Report Number | 2184009-2015-00026 |
Device Sequence Number | 1 |
Product Code |
DWF
|
Combination Product (y/n) | N |
Reporter Country Code | BE |
PMA/PMN Number | K875353 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,Company Representative,company representati |
Reporter Occupation |
Health Professional
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
07/28/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/31/2018 |
Device Model Number | 57417 |
Device Catalogue Number | 57417 |
Device Lot Number | 2015016317 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/05/2015 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
06/05/2015 |
Initial Date FDA Received | 07/02/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/22/2015 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | Z-1914-2015 |
Patient Sequence Number | 1 |