MAUDE Adverse Event Report: STOCKERT GMBH STOCKERT EP-SHUTTLE RADIO FREQUENCY GENERATOR; RADIOFREQUENCY GENERATOR AND ACCESSORIES/ACCESSORY CABLE

Model Number 39D-76X

Device Problem Insufficient Information (3190)

Patient Problems Anemia (1706); Bacterial Infection (1735); Stroke/CVA (1770); Death (1802); Fever (1858); Fistula (1862); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Seizures (2063); Malaise (2359); Laceration(s) of Esophagus (2398); Test Result (2695)

Event Date 04/05/2014

Event Type  Death  

Event Description

During a pulmonary vein isolation (pvi) procedure, the physician isolated all four pulmonary veins and since the patient was in atrial flutter, a roof line was performed.The procedure was finished with no patient consequences.After three weeks from the procedure, the patient did not feel well and visited the center in (b)(6).The patient underwent a nasogastric intubation and endoscopy which revealed lesions in the esophagus.The patient deceased.On (b)(6), received additional information requested from bwi representative stating that the consequence of the procedure was an atrial-esophageal fistula.The patient passed away.The patient presented with epileptic seizures and fever; blood cultures were positive for different bacteria.Cerebral ct was without abnormalities.Thoraco-abdominal ct-scan revealed coagulated blood in stomach with a hemoglobinemia of 7 mg/dl, decision was taken to perform a gastroscopy to research bleeding source.During gastroscopy, blood pressure dropped and cardiac actions stopped due to a hemorrhagic stroke.The physician¿s opinion regarding the causality of this event was procedure related.

Manufacturer Narrative

The equipment investigation is still in progress.Concomitant bwi products: product: carto 3 system, us catalog # fg540000, serial # (b)(4).Product: coolflow irrigation pump: us catalog # cfp001, serial # unknown.Product: webster cs catheter with ez steer technology and auto id: us catalog # bd710df282ct, lot # unknown.(b)(4) are related to the same event.

Manufacturer Narrative

(b)(4).During a pulmonary vein isolation (pvi) procedure, the physician isolated all four pulmonary veins and since the patient was in atrial flutter, a roof line was performed.The procedure was finished with no patient consequences.After three weeks from the procedure, the patient did not feel well and visited the center in (b)(4).The patient underwent a nasogastric intubation and endoscopy which revealed lesions in the esophagus.The patient deceased.The customer did not report any malfunction of the system and no service was requested for this equipment.The equipment is working within manufacturer specification.The device history record was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.

• Brand Name: STOCKERT EP-SHUTTLE RADIO FREQUENCY 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-79 111; GM D-79111
• Manufacturer Contact: jaime chavez ; 15715 arrow hwy; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3777464
• MDR Text Key: 4431657
• Report Number: 9612355-2014-00023
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P990071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/16/2014

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: 39D-76X
• Device Catalogue Number: 39D-76X
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/15/2014
• Initial Date FDA Received: 04/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 68 YR
• Patient Weight: 74