MAUDE Adverse Event Report: ATRICURE, INC. CANNULA ACCESSORIES

Model Number CSK-6130

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

Patient Problems Abdominal Pain (1685); Vomiting (2144); Hernia (2240)

Event Type  Injury  

Manufacturer Narrative

(b)(4) the device was not returned for evaluation and a device history review was unable to be completed as the relevant lot number was not reported.There was no reported device malfunction.

Event Description

During a literature search, atricure determined a patient experienced an adverse event prior to 2019 which may have been caused or contributed to by the csk-6130 cannula.In a 2019 published case study within "the journal of the college of physicians and surgeons-pakistan", literature reports a patient presented to surgical assessment unit with symptoms of worsening abdominal pain and vomiting.The patient underwent a convergent procedure via transdiaphragmatic approach at another hospital three years earlier.Ct scan of abdomen and pelvis revealed herniation of small bowel into the lower mediastinum, causing proximal small bowel obstruction.The diaphragmatic defect was closed primarily by suturing.The patient was discharged to home with follow-up in outpatient clinic.There was no reported device malfunction and the adverse event was the result of a procedural complication.Sub-xiphoid access is the preferred approach for the convergent procedure.Source: fahim m, campbell-smith t.Strangulated intrapericardial diaphragmatic hernia after hybrid maze procedure.J coll physicians surg pak.2019 dec;29(12):s95-s97.Doi: 10.29271/jcpsp.2019.12.S95.Pmid: 31779754.

• Brand Name: CANNULA ACCESSORIES
• Type of Device: CANNULA ACCESSORIES
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer (Section G): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: john ehlert ; 7555 innovation way; mason, OH 45040 ; 5136448220
• MDR Report Key: 18717651
• MDR Text Key: 335523503
• Report Number: 3011706110-2024-00011
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K193162
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CSK-6130
• Device Catalogue Number: CSK-6130
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male