MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2011-10-05 for RADISTOP C11177 NA manufactured by St. Jude Medical Sys Ab.
[2216757]
A radistop was used on a radial puncture after a pci procedure. The pt was returned to his room on the cardiology unit and after 2 hours, the velcro band came off and bleeding occurred. Manual compression was applied and hemostasis was achieved. The pt did not experience any adverse consequences.
Patient Sequence No: 1, Text Type: D, B5
[9366842]
As the product was not returned, we were unable to identify a definitive root cause. We do not believe that there is any evidence of device malfunction or any deficiency with the instructions for use requiring corrective action. We will continue to closely monitor the performance of this product for any significant trends. We have reviewed our design history record and confirmed that this batch met mfg requirements prior to shipment.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030904-2011-00011 |
| MDR Report Key | 2297459 |
| Report Source | 01,05,06,07 |
| Date Received | 2011-10-05 |
| Date of Report | 2011-09-07 |
| Date of Event | 2011-09-07 |
| Date Mfgr Received | 2011-09-07 |
| Device Manufacturer Date | 2011-03-01 |
| Date Added to Maude | 2011-10-18 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANNA JUHLEN |
| Manufacturer Street | PALMBLADSGATAN 10 BOX 6350 |
| Manufacturer City | UPPSALA SE-751 35 |
| Manufacturer Country | SW |
| Manufacturer Postal | SE-751 35 |
| Manufacturer Phone | 8161000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RADISTOP |
| Generic Name | TOURNIQUET, NONPNEUMATIC |
| Product Code | GAX |
| Date Received | 2011-10-05 |
| Model Number | C11177 |
| Catalog Number | NA |
| Lot Number | 112760 |
| ID Number | NA |
| Device Expiration Date | 2013-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL SYS AB |
| Manufacturer Address | PALMBLADSGATAN 10 BOX 6350 UPPSALA SE-751-3 SW SE-751-35 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-10-05 |