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 Problem Pain (1994)

Event Date 11/01/2015

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, 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 is received in the future we will reopen the complaint and perform the investigation as appropriate.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)(4).Concomitant product: myostar, model #: d-1211-19-si, lot #: 16041567m.(b)(4).

Event Description

It was reported that a (b)(6) female patient underwent a teva dream hf protocol (c41750-3100) procedure with a nogastar catheter and suffered an atrial fibrillation, chest pain, shortness of breath, and tachycardia requiring medication and an implantable cardioverter defibrillator (icd) adjustment.On (b)(6) 2015, the teva procedure was conducted.On (b)(6) 2015, the patient was discharged home.Five days post-procedure, the patient returned to the hospital complaining of chest pain.Troponin was mildly elevated and it was thought to be related to the teva procedure, rather than a new event.On (b)(6) 2015, the patient was discharged home.On (b)(6) 2015, the patient was re-admitted with complaints of chest pain, shortness of breath, tachycardia, and atrial fibrillation requiring an icd discharge.The icd interrogation report revealed a diagnosis of rapid atrial fibrillation but then erroneously diagnosed a ventricular tachycardia which led to failed anti-tachycardia pacing (atp) followed by a shock that restored the patient to normal sinus rhythm.The icd was then re-programmed with stricter discrimination.Treatment included iv amiodarone.During hospitalization, the patient had an abnormal chest radiograph and was treated with antibiotics.On (b)(6) 2015, the patient was discharged home.The patient fully recovered with no residual effects.The physician did not provide a causality opinion.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 5/17/2016.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.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that a (b)(6) female patient underwent a teva dream hf protocol (c41750-3100) procedure with a nogastar catheter.Five days post-procedure, the patient returned to the hospital complaining of chest pain.Troponin was mildly elevated and it was thought to be related to the teva procedure, rather than a new event.On (b)(6) 2015, the patient was discharged home.On (b)(6) 2015, the patient was re-admitted with complaints of chest pain, shortness of breath, tachycardia, and atrial fibrillation requiring an icd discharge.The icd interrogation report revealed a diagnosis of rapid atrial fibrillation but then erroneously diagnosed a ventricular tachycardia which led to failed anti-tachycardia pacing (atp) followed by a shock that restored the patient to normal sinus rhythm.The icd was then re-programmed with stricter discrimination.Treatment included iv amiodarone.During hospitalization, the patient had an abnormal chest radiograph and was treated with antibiotics.On (b)(6) 2015, the patient was discharged home.The patient fully recovered with no residual effects.Upon receipt, the catheter was visually inspected and it was found in normal conditions.A deflection, carto and electrical tests were performed and the device passed all specifications.No error found.The catheter is working properly.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.

• 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: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 5610452
• MDR Text Key: 43767656
• Report Number: 2029046-2016-00035
• 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: 04/06/2016

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: 06/30/2016
• Device Model Number: 120707S
• Device Catalogue Number: 120707S
• Device Lot Number: 15925892M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/06/2016
• Initial Date FDA Received: 04/26/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/17/2016; 06/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2013
• 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
• Patient Age: 71 YR
• Patient Weight: 98