MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. CORVOCET COAXIAL INTRODUCER; BIOPSY NEEDLE KIT

Model Number	00884450333327
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that the biopsy device broke off and the tip of the coaxial introducer remained within the patient's body during a bone biopsy.The separated portion was approx.1 cm in length and it remained in the body.Secondary procedure is required for the remainder, although it has not been scheduled yet.The condition of the patient has not been changed after the event, except for the tip detachment itself.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed; however, the root cause was attributed to clinical use contraindicated in the instructions for use (ifu) of the device.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: CORVOCET COAXIAL INTRODUCER
• Common Device Name: BIOPSY NEEDLE KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, ut
• MDR Report Key: 10398856
• Report Number: 1721504-2020-00062
• Device Sequence Number: 3168187
• Product Code: FCG
• UDI-Device Identifier: 00884450333327
• UDI-Public: 00884450333327
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2020

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: 09/30/2021
• Device Model Number: 00884450333327
• Device Catalogue Number: CORC1610/A
• Device Lot Number: H1429679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 10/14/2020
• 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: Required Intervention