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 2011-05-27 for RADISTOP C11177 manufactured by St. Jude Medical Systems Ab.
[2053666]
A radistop was applied following radial coronary angiography. Afterward, on the nursing unit, the radistop was caught on the sleeve of the pt gown and the compression pad became displaced causing arterial bleeding. Manual pressure was immediately applied and the cath lab was notified and replaced the radistop compression pad. There were no consequences to the pt since bleeding was immediately controlled.
Patient Sequence No: 1, Text Type: D, B5
[9132047]
We have reviewed our device history record and confirmed that this batch met mfg requirements prior to shipment. 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 a device malfunction or any deficiency with the instruction for use requiring corrective action. We will continue to closely monitor the performance of this product for any significant trends. The ifu advise the user that the excess part of the velcro strap can be cut or fixed (thread under the compression pad strap).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030904-2011-00005 |
| MDR Report Key | 2121301 |
| Report Source | 01,05,06,07 |
| Date Received | 2011-05-27 |
| Date of Report | 2011-05-27 |
| Date of Event | 2011-05-13 |
| Date Mfgr Received | 2011-05-13 |
| Device Manufacturer Date | 2010-01-01 |
| Date Added to Maude | 2011-06-15 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2011-05-27 |
| Model Number | C11177 |
| Lot Number | 105527 |
| Device Expiration Date | 2011-10-01 |
| 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 SYSTEMS AB |
| Manufacturer Address | PALMBLADSGATAN 10 BOX 6350 UPPSALA SE-75135 SW SE-75135 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-05-27 |