MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-15 for TEMNO EVOLUTION CTT1811 manufactured by Merit Medical Systems Mexico.
[175183551]
The suspect device is expected to return for evaluation. A follow up report will be submitted when the evaluation is complete.
Patient Sequence No: 1, Text Type: N, H10
[175183552]
The account alleges that during lung biopsy procedure, the biopsy needle tip detached within the patient. The patient was previously diagnosed with copd and suffered from aichmophobia. The hospital alleged that the patient would not lie still during the biopsy procedure. Eventually the patient's oxygen saturations started to decrease, and a code was called. Hospital bls protocols were administered requiring intubation and necessary resuscitation attempts. The needle tip was successfully removed via surgical excision.
Patient Sequence No: 1, Text Type: D, B5
[185356794]
Part of the suspect device has been returned for evaluation. The product was examined visually. The complaint is confirmed. The root cause could not be determined. A search of the complaint database was performed and no similar complaints for this lot number were found. The device history record was reviewed and no exception documents were found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3011642792-2020-00001 |
| MDR Report Key | 9594321 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-15 |
| Date of Report | 2019-12-17 |
| Date of Event | 2019-12-13 |
| Date Mfgr Received | 2020-01-30 |
| Device Manufacturer Date | 2018-08-21 |
| Date Added to Maude | 2020-01-15 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DAVID LOCKRIDGE |
| Manufacturer Street | 1600 MERIT PARKWAY |
| Manufacturer City | SOUTH JORDAN UT 84095 |
| Manufacturer Country | US |
| Manufacturer Postal | 84095 |
| Manufacturer Phone | 8012084551 |
| Manufacturer G1 | MERIT MEDICAL SYSTEMS MEXICO |
| Manufacturer Street | 8830 SIEMPRE VIVA RD #100 |
| Manufacturer City | SAN DIEGO CA 92154 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92154 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEMNO EVOLUTION |
| Generic Name | BIOPSY NEEDLE |
| Product Code | FCG |
| Date Received | 2020-01-15 |
| Returned To Mfg | 2020-01-17 |
| Model Number | CTT1811 |
| Catalog Number | CTT1811 |
| Lot Number | 0001251374 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERIT MEDICAL SYSTEMS MEXICO |
| Manufacturer Address | 8830 SIEMPRE VIVA RD #100 SAN DIEGO CA 92154 US 92154 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-01-15 |