MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-22 for DS2M042 manufactured by St. Jude Medical, Inc.(crm-sylmar).
[87160135]
It was reported that the patient presented to the operating room for surgical procedure. During procedure, dissection of patient? S vein was noted upon introducing the catheter into the vein. The patient was asymptomatic to the dissection. On (b)(6) 2017 a thoracic scan revealed the presence of blood was confirmed. It was noted that pleural effusion was not present, and no drainage was performed. No system upgrade procedure was scheduled. The patient? S condition was stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017865-2017-32275 |
| MDR Report Key | 6888867 |
| Date Received | 2017-09-22 |
| Date of Report | 2017-09-22 |
| Date of Event | 2017-08-22 |
| Date Mfgr Received | 2017-08-22 |
| Device Manufacturer Date | 2016-04-15 |
| Date Added to Maude | 2017-09-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DENISE JOHNSON |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517564470 |
| Manufacturer G1 | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
| Manufacturer Street | 15900 VALLEY VIEW COURT |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91342 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | CPS DIRECT ME 115 |
| Product Code | JAA |
| Date Received | 2017-09-22 |
| Model Number | DS2M042 |
| Lot Number | 5987343 |
| ID Number | 05414734509473 |
| Device Expiration Date | 2019-04-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
| Manufacturer Address | 15900 VALLEY VIEW COURT SYLMAR CA 91342 US 91342 |
| Generic Name | CPS DIRECT ME 115 |
| Product Code | NAF |
| Date Received | 2017-09-22 |
| Model Number | DS2M042 |
| Lot Number | 5987343 |
| ID Number | 05414734509473 |
| Device Expiration Date | 2019-04-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
| Manufacturer Address | 15900 VALLEY VIEW COURT SYLMAR CA 91342 US 91342 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-22 |