MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-07-09 for SUCTION 12118 LV VENT 18FR PVC 20PK 17L manufactured by Perfusion Systems.
[79353871]
The product has not been received by medtronic and the investigation is in progress. Without the return of the product, no definitive conclusion can be made regarding the clinical observation. Should the product be returned, additional information received, or if the completed investigation yields new information, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[79353872]
Medtronic received information that during cannulation, the cannula was placed through the atrial septum and perforated the posterior wall of the left atrium of the heart. The surgeon sutured the wall of the atrium. There were no further adverse patient effects.
Patient Sequence No: 1, Text Type: D, B5
[101857949]
The device is not available for analysis because it was discarded by the customer. Without the return of the product, no definitive conclusion can be made regarding the clinical observation in this event. The device history record was reviewed and showed this product met all manufacturing specifications for product released for distribution. No issues were identified in the device history record that would have contributed to this event. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[101857950]
Medtronic received information that during cannulation, the cannula was placed through the atrial septum and perforated the posterior wall of the left atrium of the heart. The surgeon sutured the wall of the atrium. There were no further adverse patient effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184009-2017-00024 |
| MDR Report Key | 6696295 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-07-09 |
| Date of Report | 2017-08-28 |
| Date of Event | 2017-05-01 |
| Date Mfgr Received | 2017-08-28 |
| Device Manufacturer Date | 2016-09-21 |
| Date Added to Maude | 2017-07-09 |
| 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 | 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 | SUCTION 12118 LV VENT 18FR PVC 20PK 17L |
| Generic Name | SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS |
| Product Code | DTS |
| Date Received | 2017-07-09 |
| Model Number | 12118 |
| Catalog Number | 12118 |
| Lot Number | 2016081208 |
| Device Expiration Date | 2019-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-07-09 |