MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OCTARAY, GALAXY, 48P, 2-5-2-5-2, D-CURVE; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Catalog Number	D160902
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unspecified ablation procedure with a octaray, galaxy, 48p, 2-5-2-5-2, d-curve and post procedure the medical team identified char on the splines.The octaray was used following the ifu (instructions for use).Total ablation time approximately 90 mins and rf (radiofrequency) energy was delivered in 35w.No patient consequences were reported.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc.Or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On 15-nov-2023, the photo analysis was completed.Device investigation details: a picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, chars were observed in electrodes of three splines.The customer complaint was confirmed based on the picture received.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: OCTARAY, GALAXY, 48P, 2-5-2-5-2, D-CURVE
• Common Device Name: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17918204
• Report Number: 2029046-2023-02299
• Device Sequence Number: 6804305
• Product Code: MTD
• UDI-Device Identifier: 10846835021110
• UDI-Public: 10846835021110
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K193237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: D160902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown