MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-18 for DYNJ0378596F manufactured by Medline Industries Inc..
[120693438]
It was reported that during a right and left heart cath procedure the forceps punctured an unidentified femoral artery. Reportedly, this occurred as the cardiologist was using the forceps to spread the patient's skin after making an incision. Manual pressure was "held for hemostasis" over the puncture site. The patient was not under general anesthesia at the time of this incident. The procedure did not last longer than expected. There was no reported impact to the procedure, the patient, or the patient's stability. After an unidentified period of time a femoral ultrasound was performed with no adverse findings reported. No sample was returned to the manufacturer for evaluation. A root cause could not be determined. Due to the reported incident, and in an abundance of caution, this medwatch is being filed. If additional information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[120693439]
It was reported that during a right and left heart cath procedure the forceps punctured an unidentified femoral artery.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1423395-2018-00044 |
MDR Report Key | 7887313 |
Date Received | 2018-09-18 |
Date of Report | 2018-09-18 |
Date of Event | 2018-08-24 |
Date Mfgr Received | 2018-08-24 |
Date Added to Maude | 2018-09-18 |
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 | 3 |
Event Location | 3 |
Manufacturer Contact | NIGEL VILCHES |
Manufacturer Street | THREE LAKES DRIVE |
Manufacturer City | NORTHFIELD IL 600932753 |
Manufacturer Country | US |
Manufacturer Postal | 600932753 |
Manufacturer Phone | 2249311458 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Generic Name | FORCEPS IN CATH LAB DRAPE PACK-LF |
Product Code | OES |
Date Received | 2018-09-18 |
Catalog Number | DYNJ0378596F |
Lot Number | 18GBN757 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MEDLINE INDUSTRIES INC. |
Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 600932753 US 600932753 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2018-09-18 |