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

Catalog Number 261221

Device Problem Entrapment of Device (1212)

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

2 of 2 reports.Same procedure, same patient, different products.Other mfg report number: 3014334038-2021-00055.A facility reported the patient's dura tore due to disengagement failure of the perforator during a craniectomy for evacuation of a subdural hematoma on (b)(6) 2021.The dura was repaired with a dural substitute.The perforator was then used to drill another burr hole and failed to stop again.The surgeon got a second perforator and that perforator got stuck in the patients skull.The surgeon had to use a mallet to remove the perforator.There was a 90 second surgical delay when the disengagement occurred.There was a 120 second surgical delay when the drill was stuck in the skull and had to be removed from the patients head with a mallet.The patient expired on (b)(6) 2021 due to brain death.A postmortem examination or autopsy were not performed.Stryker was the manufacturer of the pneumatic drill used with the perforator.The perforator reportedly clicked into place in the drill.

Event Description

N/a.

Manufacturer Narrative

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 units were inspected using the unaided eye.Both units returned were heavily soiled from surgery and had worn/damaged blue sleeves.The "ifu" testing procedure was performed.One unit was slightly fused and freed under light pressure, the second unit could not be tested as it was returned and organic matter had to be removed by cleaning the unit with 70% "ipa" solution.Functional testing was performed using the same protocol it underwent at finished goods testing prior to release.The units were found to perform as intended and fulfilled the acceptance criteria.In the failure analysis that was performed, the returned units were 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.Product was received for analysis and the investigation could not confirm the complaint.Based on a medical assessment requested: the use of the perforators and its performance were not seen to be associated with the demise of this patient.The patient presented with a subdural hematoma that needed urgent surgical intervention.Subdural hematomas may be a result of a significant head trauma or injury.The subdural hematoma may have been larger or severe since a craniectomy was performed to evacuate it.There was only minimal surgical delay as a result of the reported malfunctions.The dural tear was successfully repaired.Complainant confirmed patient death was not due to product failure.

• Brand Name: CODMAN DISPOS PERFORATOR
• Type of Device: DISPOSABLE PERFORATORS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• MDR Report Key: 11599764
• MDR Text Key: 243310825
• Report Number: 3014334038-2021-00056
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• 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: J7408Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death