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 2020-03-30 for SENSATION PLUS 8FR. 50CC 0684-00-0575 manufactured by Datascope Corp. - Fairfield.
[185517792]
The product has been returned to the manufacturer, but is pending investigation. Once the investigation is completed a supplemental report with our findings will be submitted. Complaint#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185517793]
It was reported after insertion of the intra-aortic balloon(iab) using a competitor sheath, the console generated a catheter restriction alarm. Staff suggested to the doctor to pull the sheath back slightly. The doctor removed the balloon and inserted second different size balloon to continue therapy. There was no reported injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2248146-2020-00175 |
| MDR Report Key | 9897473 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-07 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-12-09 |
| Date Added to Maude | 2020-03-30 |
| 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 | MS. DOROTA WOLPIUK |
| Manufacturer Street | 15 LAW DRIVE |
| Manufacturer City | FAIRFIELD NJ 07004 |
| Manufacturer Country | US |
| Manufacturer Postal | 07004 |
| Manufacturer G1 | DATASCOPE CORP. - FAIRFIELD |
| Manufacturer Street | 15 LAW DRIVE |
| Manufacturer City | FAIRFIELD NJ 07004 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENSATION PLUS 8FR. 50CC |
| Generic Name | SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL |
| Product Code | DSP |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-17 |
| Catalog Number | 0684-00-0575 |
| Lot Number | 3000110617 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DATASCOPE CORP. - FAIRFIELD |
| Manufacturer Address | 15 LAW DRIVE FAIRFIELD NJ 07004 US 07004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |