MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS

Catalog Number 261221

Device Problems Break (1069); Fail-Safe Did Not Operate (4046)

Patient Problem Brain Injury (2219)

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A physician reported a codman perforator (id: 261221) did not stop and separated into two parts during the procedure: a patient was admitted due to stroke and a physician planned to do one hole puncture.After high-speed drill machine was started, the perforator drilled into the skull then it was torn apart.The distal part stuck into the patient¿s skull and damage the dura.The patient had also brain trauma at the location of the hole and has been moved to in-patient department (ipd).The physician repaired the patient's dura and admitted him to intensive care unit (icu) a couple days until he recovered on (b)(6) 2024.The manufacturer of the drill used with the perforator is an electric medtronic.The perforator clicked in place in the drill and the recommended spring tests were performed between each burr hole.There was 90-degree angle of approach perpendicular as the instruction for use (ifu) states.The perpendicular approach was maintained through the drilling process and there was a constant downward pressure.

• Brand Name: CODMAN DISPOS PERFORATOR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18966527
• MDR Text Key: 338434268
• Report Number: 3014334038-2024-00060
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• PMA/PMN Number: K791101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 261221
• Device Lot Number: 7292848
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ELECTRIC MEDTRONIC.
• Patient Age: 65 YR
• Patient Sex: Male