MAUDE Adverse Event Report: RAYNHAM CODMAN DISPOS PERFORATOR; DISPOSABLE PERFORATORS

Catalog Number 261221

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Laceration(s) (1946)

Event Date 09/30/2020

Event Type  Injury  

Manufacturer Narrative

Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported the perforator failed to disengage.The patient underwent a right frontal external ventricular drain insertion for post meningitis hydrocephalus.A codman perforator was used to make a burr hole, failed to disengage, and did not stop after coring the inner table and the dura was breached.The small area of underlying brain lacerated (about 5mm).There was no major bleeding or major vessel injury from the breach.Hemostasis was achieved and the external ventriculostomy drain was inserted successfully.The drill was an electric drill manufactured by medtronic, model: ipc (integrated power console).The perforator reportedly clicked in place in the drill and the recommended spring tests were performed between each burr hole.The scrub nurse ensured the drill was working and tested and ran for a few seconds with the perforator.

Manufacturer Narrative

Unique device identifier (udi) : (b)(4).The perforator was returned for evaluation: device history record (dhr) - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the perforator unit was inspected using the unaided eye.Visual inspection showed a slightly soiled perforator, and slightly damaged "eto" label.Ifu testing procedure was performed with no observed anomalies.Functional testing was performed; the unit was found to perform as intended and fulfilled the acceptance criteria.In the failure analysis that was performed, the returned unit was found to work as intended, and met all acceptance criteria.The complaint could not be verified through failure analysis.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.

• Brand Name: CODMAN DISPOS PERFORATOR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10731450
• MDR Text Key: 212995189
• Report Number: 3014334038-2020-00075
• 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
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• 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: J6956W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1