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

Model Number 00884450333327

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problems Needle Stick/Puncture (2462); Device Embedded In Tissue or Plaque (3165)

Event Date 08/06/2020

Event Type  Injury  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event 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.

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
• Type of Device: BIOPSY NEEDLE KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, ut
• MDR Report Key: 10398856
• MDR Text Key: 202695896
• Report Number: 1721504-2020-00062
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00884450333327
• UDI-Public: 00884450333327
• Combination Product (y/n): N
• PMA/PMN Number: K151373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 10/05/2020
• Supplement Dates FDA Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention