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 2015-09-24 for ACU10135936 manufactured by Sterilmed, Inc..
[26616789]
It was reported that the device was disposed of by the customer, it will not be returned for evaluation. The device history record was reviewed and no discrepancies were found.
Patient Sequence No: 1, Text Type: N, H10
[26616790]
It was reported that during an asd closure, a pericardial effusion was noticed and confirmed by ice. Caller reported that protamine was administered to the patient and the effect of heparin was reversed. The patient was reported to be in stable condition. Upon request for additional information, it was reported that it was not thought that the ice catheter caused the effusion. It was assumed that the gore device or the sheath for the gore device caused the effusion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2134070-2015-00047 |
| MDR Report Key | 5100260 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2015-09-24 |
| Date of Report | 2015-09-04 |
| Date of Event | 2015-09-02 |
| Date Mfgr Received | 2015-09-04 |
| Device Manufacturer Date | 2015-04-23 |
| Date Added to Maude | 2015-09-24 |
| 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 | JAY ANDERSON |
| Manufacturer Street | 11400 73RD AVE N |
| Manufacturer City | PLYMOUTH MN 55446 |
| Manufacturer Country | US |
| Manufacturer Postal | 55446 |
| Manufacturer Phone | 7634888348 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | REPROCESSED INTRAVASCULAR ULTRASOUND CATHETER |
| Product Code | OWQ |
| Date Received | 2015-09-24 |
| Model Number | ACU10135936 |
| Catalog Number | ACU10135936 |
| Lot Number | 1861721 |
| Device Expiration Date | 2016-04-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERILMED, INC. |
| Manufacturer Address | 11400 73RD AVE N MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-09-24 |