MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-01-16 for THERMODILUTION CATH KIT: 7.5 FR 5-L IPN036076 AH-05050-G manufactured by Arrow International Inc..
[180193521]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[180193522]
It was reported that "during use on the patient the physician inserted the catheter and was able to measure pressures in ra (right atrium), rv (right ventricle) and svc (superior vena cava) but was unable to reach the pulmonary artery. It was reported that a second catheter was used but the therapy was not finished. Clinical consequences: there were no report of any clinical consequence or patient complications. In the meanwhile the patient was discharged home from the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518433-2020-00001 |
| MDR Report Key | 9597297 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-01-16 |
| Date of Report | 2019-12-30 |
| Date of Event | 2019-12-20 |
| Date Mfgr Received | 2019-12-30 |
| Device Manufacturer Date | 2019-06-17 |
| Date Added to Maude | 2020-01-16 |
| 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 | CARMEN SHERMAN |
| Manufacturer Street | 16 ELIZABETH DRIVE |
| Manufacturer City | CHELMSFORD MA 01824 |
| Manufacturer Country | US |
| Manufacturer Postal | 01824 |
| Manufacturer Phone | 9782505100 |
| Manufacturer G1 | ARROW INTERNATIONAL INC. |
| Manufacturer Street | 16 ELIZABETH DRIVE |
| Manufacturer City | CHELMSFORD MA 01824 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01824 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERMODILUTION CATH KIT: 7.5 FR 5-L |
| Generic Name | CATHETER, FLOW DIRECTED |
| Product Code | DYG |
| Date Received | 2020-01-16 |
| Returned To Mfg | 2020-01-22 |
| Model Number | IPN036076 |
| Catalog Number | AH-05050-G |
| Lot Number | 71F19E3167 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW INTERNATIONAL INC. |
| Manufacturer Address | READING PA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-16 |