MAUDE Adverse Event Report: ARTHROCARE CORPORATION UNKNOWN COBLATION ENT DEVICE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Apnea (1720); Bradycardia (1751)

Event Date 07/01/2017

Event Type  Injury  

Manufacturer Narrative

H10: internal complaint reference (b)(4).

Event Description

It was reported that after an intracapsular tonsillectomy, adenoidectomy and drug-induced endoscopy, direct laryngoscopy and bronchoscopy using a coblation wand, patient had 1 episode of apnea and bradycardia requiring albuterol and racemic epinephrine.Patient was admitted to picu for airway monitoring and put on full mask bipap throughout the night.Once removed in the morning, patient tolerated it well.No outcomes reported at last evaluation.

Manufacturer Narrative

Internal complaint reference (b)(4).H10 h3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined due to the limited clinical information provided.Insufficient product identification information was provided and thus a manufacturing record review, complaint history review, instruction for use review and a risk management review, could not be conducted.Based on the information available, there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A clinical review states that the likely clinical root cause of the reported apnea and bradycardia is the patient history of obstructive sleep disordered breathing (osdb)/obstructive sleep apnea (osa) as well as the anesthesia sedation and not related to the coblation wand device or its use.The patient impact is the over-night icu stay and treatment with albuterol, racemic epinephrine and full mask bipap.Based on the limited information provided we are unable to conclude on factors known to contribute to the alleged report.No containment or corrective actions are recommended at this time.Internal complaint reference (b)(4).H11 b1: only adverse event should be marked as yes.

• Brand Name: UNKNOWN COBLATION ENT DEVICE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORPORATION; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18194757
• MDR Text Key: 328828490
• Report Number: 3006524618-2023-00455
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K202006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 1 YR
• Patient Sex: Female