MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-12 for TRANSFORM SUPER COMPLIANT 4MM X 10MM- CE M003ESC04100 manufactured by Stryker Neurovascular Cork.
[179336646]
The device is not available to the manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[179336647]
It was reported that during the procedure the balloon catheter was found to be leaking within artery. The procedure was completed successfully and there were no clinical consequences were reported to the patient due to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008881809-2020-00040 |
| MDR Report Key | 9703650 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-01-24 |
| Date Mfgr Received | 2020-01-24 |
| Date Added to Maude | 2020-02-12 |
| 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 | MR. TARA LOPEZ |
| Manufacturer Street | 47900 BAYSIDE PARKWAY |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal | 94538 |
| Manufacturer Phone | 5104132500 |
| Manufacturer G1 | STRYKER NEUROVASCULAR CORK |
| Manufacturer Street | IDA INDUSTRIAL ESTATE MODEL FARM ROAD |
| Manufacturer City | CORK NA |
| Manufacturer Country | IE |
| Manufacturer Postal Code | NA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSFORM SUPER COMPLIANT 4MM X 10MM- CE |
| Generic Name | CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY |
| Product Code | MJN |
| Date Received | 2020-02-12 |
| Catalog Number | M003ESC04100 |
| Lot Number | 21321700 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER NEUROVASCULAR CORK |
| Manufacturer Address | IDA INDUSTRIAL ESTATE MODEL FARM ROAD CORK NA IE NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-12 |