MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-28 for MAHURKAR 8888101002HP manufactured by Covidien Mfg Solutions S.a..
[146260197]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[146260198]
According to the reporter, patient was on an emergent case and came in with chest pain and needed stent placement, during the placement of triple lumen dialysis catheter, the patient was placed in the supine position in mild trendelenberg. Under ultrasound guidance, the left femoral vein was identified. The patient was then draped and prepped in the usual sterile manner. After adequate local anesthesia was obtained, the vein was cannulated. Using seldinger technique, a guide wire was advanced without resistance. Imaging of the guidewire confirm that guidewire outside vein. Guidewire was removed and was found to be kinked and all became unraveled with fixed resistance at one point. Available dilator was applied, and the guidewire retracted but was unsuccessful. Smaller dilator was used and with retraction, successfully removed (complete). Pressure was applied to area until hemostasis. At the second attempt, using seldinger technique, a guide wire was advanced without resistance. After the subcutaneous skin was appropriately dilated, a fr (french) 20 cm triple lumen dialysis catheter was placed. Both dialysis ports and third access port were easily aspirated and flushed with normal saline and the catheter sutured to the skin using 2-0 silk. The catheter was in place for five (5) days before the patient expired. It was later reported that the patient was deceased, and cardiogenic shock was determined to be the cause of death. It is unknown at this time if the device caused or contributed to the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2019-00131 |
| MDR Report Key | 8646769 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-28 |
| Date of Report | 2019-09-04 |
| Date of Event | 2019-04-04 |
| Date Mfgr Received | 2019-08-09 |
| Device Manufacturer Date | 2018-02-10 |
| Date Added to Maude | 2019-05-28 |
| 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 | LISA HERNANDEZ |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | COVIDIEN MFG SOLUTIONS S.A. |
| Manufacturer Street | EDIFICIO B20, CALLE #2 |
| Manufacturer City | ALAJUELA 20101 |
| Manufacturer Postal Code | 20101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAHURKAR |
| Generic Name | CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED |
| Product Code | NIE |
| Date Received | 2019-05-28 |
| Returned To Mfg | 2019-08-08 |
| Model Number | 8888101002HP |
| Catalog Number | 8888101002HP |
| Lot Number | 1803700080 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN MFG SOLUTIONS S.A. |
| Manufacturer Address | EDIFICIO B20, CALLE #2 ALAJUELA 20101 20101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-05-28 |