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

Catalog Number	120707S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	05/09/2018
Type of Reportable Event	Serious Injury
Additional 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.Concomitant medical product: myostar¿ injection catheter (model# d-1211-19-si, lot# 17618520m).Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent an intra-myocardial stem cell injection procedure for heart failure with a noga-star¿ cardiology catheter and suffered a myocardial infarction requiring no medical or surgical intervention.During left heart catheterization, elevated troponin levels were confirmed via lab analysis.There were no interventions.Patient was reported to be in stable condition.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.
Additional Manufacturer Narrative
It was reported that a patient underwent an intra-myocardial stem cell injection procedure for heart failure with a noga-star¿ cardiology catheter and suffered a myocardial infarction requiring no medical or surgical intervention.The investigational analysis has been completed.The catheter was visually inspected and it was found in normal conditions.Carto, and coil disconnection tests were performed and the catheter passed all specifications.No error was found.Electrical testing was performed.Results passed.Deflection tests were performed and the results passed.Product is working properly.The complaint was not confirmed.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.Manufacture ref no: (b)(4).
Additional Manufacturer Narrative
Additional information received on 6/19/2018.The event occurred on a (b)(6) year-old female patient post use.The patient¿s diagnosis pre ¿ procedure, was heart failure.The physician¿s opinion regarding the cause of this adverse event was that it was the procedure and or the patient¿s condition.Patient fully recovered with no residual effects.No medical or surgical intervention was required.No hospitalization or additional intervention was performed.There were no bwi ablation catheters used.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.In addition, the expiration date (2019-07-31) and manufacturing date (2016-08-10) were provided.The corresponding fields of this report have been updated.Manufacturer ref no: (b)(4).

• Brand Name: NOGA-STAR¿ CARDIOLOGY CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7567973
• Report Number: 2029046-2018-01633
• Device Sequence Number: 11202435
• Product Code: DRF
• UDI-Device Identifier: 10846835002041
• UDI-Public: 10846835002041
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K954390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 120707S
• Device Lot Number: 17545524M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 05/09/2018; 05/09/2018
• Initial Report FDA Received Date: 06/04/2018
• Supplement Report FDA Received Date: 07/12/2018; 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 60 YR
• Patient Weight: 63