MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE) NOGA-STAR¿ CARDIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 120707S

Device Problem Insufficient Information (3190)

Patient Problems Atrial Fibrillation (1729); Bradycardia (1751); Coagulation Disorder (1779); Death (1802); Swelling (2091); Electrolyte Imbalance (2196); Cardiogenic Shock (2262); Respiratory Failure (2484); No Code Available (3191)

Event Date 05/13/2015

Event Type  Death  

Event Description

It was reported that the (b)(6) male patient had undergone the study procedure using nogastar catheter (lv mapping and endomyocardial stem cell therapy vs.Placebo) on (b)(6) 2015 which was a part of dream-hf clinical trial.The patient was in stable condition prior to being discharged from hospital.The patient admitted to a hospital again for leg swelling and generalized weakness but no association to fever, chills, pnd, orthopnea, or chest pain.Patient¿s problems at the time of visit included hyperkalemia, acute kidney injury, cardiogenic shock, atrial fibrillation, acute respiratory failure, hyponatremia, coagulopathy, and bradycardia.The patient had expired on (b)(6) 2015.There was no autopsy was requested.There were no complications related to the study procedure and no anomalies were found on the catheter during the case.The physician¿s opinion regarding the cause of this adverse event is that this is not procedure related.However, since the nogastar catheter was present during this procedure, bwi takes conservative approach and reports this event under the nogastar catheter.

Manufacturer Narrative

The device history record (dhr) 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.(b)(6).(b)(4).

Manufacturer Narrative

(b)(4).It was reported that the (b)(6) male patient had undergone the study procedure using nogastar catheter (lv mapping and endomyocardial stem cell therapy vs.Placebo) on (b)(6) 15 which was a part of (b)(6) clinical trial.The patient was in stable condition prior to being discharged from hospital.The patient admitted to a hospital again for leg swelling and generalized weakness but no association to fever, chills, pnd, orthopnea, or chest pain.Patient¿s problems at the time of visit included hyperkalemia, acute kidney injury, cardiogenic shock, atrial fibrillation, acute respiratory failure, hyponatremia, coagulopathy, and bradycardia.The patient had expired on (b)(6) 2015.The returned device was visually inspected upon receipt and it was found in normal conditions.Per the event, the catheter was tested for electrical performance, temperature response and stockert compatibility and it was found within specifications.Furthermore, an irrigation test was performed and the catheter passed, no occlusion was observed.A deflection test was performed and the catheter passed.The catheter was also evaluated for carto 3.The catheter was recognized by carto 3 system, no error messages were displayed and the catheter was properly visualized.The force feature was evaluated and passed.The device history record (dhr) 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.The catheter passed all specifications patient cause of decease remains unknown.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.

• Brand Name: NOGA-STAR¿ CARDIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: shahe garabedian ; 9098397362
• MDR Report Key: 4826367
• MDR Text Key: 5838690
• Report Number: 2029046-2015-00155
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/20/2015

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 Expiration Date: 04/30/2017
• Device Model Number: 120707S
• Device Catalogue Number: 120707S
• Device Lot Number: 17020340M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/20/2015
• Initial Date FDA Received: 06/09/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/07/2015; 07/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2014
• 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): Death
• Patient Age: 48 YR
• Patient Weight: 79