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

Model Number 261221

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem Brain Injury (2219)

Event Date 08/18/2022

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 disengagement failure of a codman disposable perforator (id 261221).It occurred at making the third and the fourth burr holes at the tent.At the third burr hole, dural damage and a small hole in a fine vein were reported.A small hole in the vein was hemostated by pressure.At the fourth burr hole, dural damage and asymptomatic brain injury were reported.The drill used with the perforator was a pneumatic midas rex (medtronic).According to reporter, it is unknown if the perforator clicked in place on the drill.It is also unknown if the recommended spring tests were performed between each burr hole.

Manufacturer Narrative

Linked to mfg report number: 3014334038-2022-00238.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 - unit passed all tests / acceptance criteria and was determined to be functioning as designed.Tests performed include, functional test visual inspection, and spring test.Therefore the complaint condition could not be confirmed per the failure analysis.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.Product was received for analysis and the investigation could not confirm the complaint.The risk remains acceptable per the risk analysis.Although the complaint was not confirmed, root cause was investigated using the risk documentation and potential causes of failure include: user misuse.

• Brand Name: CODMAN DISPOS PERFORATOR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15370275
• MDR Text Key: 299376875
• Report Number: 3014334038-2022-00198
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 10381780513599
• UDI-Public: 10381780513599
• 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,Followup
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 261221
• Device Catalogue Number: 261221
• Device Lot Number: 6416524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2022
• 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