MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-22 for CDS983965D manufactured by Medtronic.
[142774017]
It was reported that the tip of the medtronic set cath placement pressure line broke off into the patient. It is unknown how the medtronic set cath placement pressure line was being handled at the time of the incident or how the tip was removed from the patient. No impact or adverse effect to the patient was reported to the pack manufacturer. No additional information was provided to the pack manufacturer. No sample was available to be returned for evaluation. Due to the reported incident, and in an abundance of caution, this medwatch is being filed. If additional relevant information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[142774018]
It was reported that the tip of the medtronic set cath placement pressure line broke off into the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423395-2019-00016 |
| MDR Report Key | 8536530 |
| Date Received | 2019-04-22 |
| Date of Report | 2019-04-22 |
| Date of Event | 2019-04-01 |
| Date Mfgr Received | 2019-04-15 |
| Date Added to Maude | 2019-04-22 |
| 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 | MEDTRONIC LINE IN DBD-OPEN HEART CDS |
| Product Code | OEZ |
| Date Received | 2019-04-22 |
| Catalog Number | CDS983965D |
| Lot Number | 18GBQ946 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Manufacturer Address | 710 MEDTRONIC PARKWAY MINNEAPOLIS MN 554325604 US 554325604 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-04-22 |