MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MEXICO TEMNO EVOLUTION; BIOPSY NEEDLE

Model Number	CTT1811
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up report will be submitted when the evaluation is complete.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: TEMNO EVOLUTION
• Common Device Name: BIOPSY NEEDLE
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS MEXICO; 8830 siempre viva rd #100; san diego CA 92154
• MDR Report Key: 9594321
• Report Number: 3011642792-2020-00001
• Device Sequence Number: 11437109
• Product Code: FCG
• UDI-Device Identifier: 10885403089343
• UDI-Public: 10885403089343
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K024120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2023
• Device Model Number: CTT1811
• Device Catalogue Number: CTT1811
• Device Lot Number: 0001251374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention