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

Model Number 261221

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/27/2022

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 disposable perforator (id 261221) causing bleeding during making the first burr hole at the tent.Hemostasis was performed.The drill used with the perforator was a midas (medtronic).Based on information provided, 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.The event did not led to surgical delay.No further information was provided by hospital.

Event Description

N/a.

Manufacturer Narrative

Additional information received: "the possibility of dural damage or vascular damage cannot be denied as the cause of the large amount of bleeding.".

Event Description

N/a.

Manufacturer Narrative

Perforator (id 261221) has been 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 - visual inspection utilizing unaided eye performed: unit had a worn label and the lot # could not be determined via visual inspection.Tooling was observed at the end of the outer drill.Spring test attempted: unit passed the spring test and was determined to function as designed.Functional test performed: unit successfully drilled 5 holes with no issues and was found to function as intended.Unit was found to meet all acceptance criteria.Therefore, the complaint condition could not be confirmed.Root cause- the root cause is undetermined and was unable to be confirmed in the complaint evaluation.Possible root cause is "user misuse" as the perforator functioned as designed and passed all acceptance criteria during the failure analysis performed.

• 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: 16158818
• MDR Text Key: 307301673
• Report Number: 3014334038-2022-00296
• 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,Followup
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 6756332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2022
• Initial Date FDA Received: 01/13/2023
• Supplement Dates Manufacturer Received: 01/19/2023; 03/23/2023
• Supplement Dates FDA Received: 02/08/2023; 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2022
• 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