MAUDE Adverse Event Report: STOCKERT GMBH STOCKERT 70 RF GENERATOR; RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE

Model Number M-5463-01

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

Patient Problems Abscess (1690); Air Embolism (1697); Stroke/CVA (1770); Infarction, Cerebral (1771); Fistula (1862); Unspecified Infection (1930); Paresis (1998); Pneumonia (2011); Visual Impairment (2138)

Event Date 01/19/2017

Event Type  Injury  

Manufacturer Narrative

Since the device serial number is unknown, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device serial number is received in the future, we will reopen the complaint and perform the investigation as appropriate.Since no serial number was provided, no device history record (dhr) review could be performed.Concomitant medical products: radiofrequency ¿hot¿ balloon, brand unspecified; esophageal temperature probe, brand unspecified.(b)(4).Seven weeks post-procedure, small esophageal cracks with minor bleeding were confirmed via endoscopy.Since the adhesions that resulted from pneumonia and the pulmonary abscess presented surgical difficulties for a right thoracotomy approach, an endoscopic clip closure technique was performed.Esophageal cracks were successfully repaired.Approximately 9-10 weeks post-procedure, a 2nd procedure repaired the ripv via a left atrial posterior wall patch.Ten weeks post-procedure, the patient remained hospitalized.Generator was in power control mode.There is no information regarding overall ablation time or last ablation cycle time at the site of injury.There were no errors observed on any bwi equipment during the procedure.

Event Description

It was reported that a 75 year old male patient underwent a pulmonary vein isolation (pvi) ablation procedure for atrial fibrillation with a stockert generator and suffered a respiratory infection, a cerebrovascular accident, and an esophageal fistula (requiring an endoscopic clip and an atrio-esophageal patch).Ablation was initially being conducted with a ¿hot¿ balloon (brand unspecified), but the left superior pulmonary vein (lspv) and right inferior pulmonary vein (ripv) could not be isolated.Radiofrequency ablation was performed on the lspv (7 o¿clock position) and the ripv (5 o¿clock position).Esophageal temperature probe was used and ablation was stopped when temperature reached 40 degrees celsius.Procedure was successfully completed.Patient required extended hospitalization as a result of the adverse events that followed.Physician¿s opinion regarding the cause of the adverse events is that they were procedure-related.Approximately 3-4 weeks post-procedure, the patient was admitted for pneumonia.Two days post-admission, the patient was diagnosed with bacteremia.Physician considered the possibility of an atrio-esophageal fistula secondary to ablation.Right-sided pneumonia and a pulmonary abscess were confirmed.Endoscopy revealed no esophageal injury at this time.Approximately 5-6 weeks post-procedure, a cerebral infarction occurred as a result of an air embolus.Patient suffered left-sided paralysis and bilateral vision issues.Approximately 6 weeks post-procedure, a 1-2mm esophageal crack without bleeding was confirmed via endoscopy.Physician speculated that an atrio-esophageal fistula may have caused an air embolus.

• Brand Name: STOCKERT 70 RF GENERATOR
• Type of Device: RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE
• Manufacturer (Section D): STOCKERT GMBH; boetzinger strasse 72; freiburg, b-w D-791 11; GM D-79111
• Manufacturer (Section G): STOCKERT GMBH; boetzinger strasse 72; freiburg, b-w D-791 11; GM D-79111
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6503620
• MDR Text Key: 73219542
• Report Number: 9612355-2017-00027
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M-5463-01
• Device Catalogue Number: S7001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2017
• Initial Date FDA Received: 04/19/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 67