MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OCTA,LNG,48P,2-5-2-5-2,F-CURVE; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number	D160905
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial filbrillation (afib) ¿ paroxysmal ablation procedure with an octaray, galaxy, 48p, 2-5-2-5-2, f-curve and an electrode damaged with foreign material issue occurred.It was reported that there were small hairs extruding from the distal end of the octaray spline.The small fibers looked like they are attached at the distal electrodes.The fibers were about 2cm long.Surgery was not delayed due to the reported event.The octaray was replaced with a new octaray catheter and the procedure was successfully completed.There were no fragments generated.There were no patient consequences.No other medical intervention was required.The electrode damaged with foreign material issue was assessed as mdr reportable.
Additional Manufacturer Narrative
Pictures were received for evaluation following biosense webster's procedures.According to the pictures provided by the customer, foreign material was observed attached to one of the splines of the octaray catheter, the foreign material looks like a plastic hair.At this time, it is not possible to determine the source of the foreign material.No other damages or anomalies were observed on the device.A manufacturing record evaluation was performed for the finished device 30786409l, and no internal actions related to the reported complaint were identified.The customer complaint was confirmed based on the picture received.However, the device has not been returned for evaluation.Since no device has been received, no product investigation can be performed.If the device is received in the future, the product analysis will be performed as appropriate in order to find the root cause of the complaint.Explanation of codes: investigation findings: environment problem identified / investigation conclusions: cause not established were selected as related to the photo analysis.Investigation findings code of "appropriate term/code not available" represents photo/video analysis.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 10-jan-2023.The device evaluation was completed on 02-feb-2023.It was reported that a patient underwent an atrial filbrillation (afib) ¿ paroxysmal ablation procedure with an octaray, galaxy, 48p, 2-5-2-5-2, f-curve and an electrode damaged with foreign material issue occurred.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation.Bwi conducted a visual inspection and functionality test of the returned device.Visual analysis revealed an electrode was squashed; no sharp parts were observed.In addition, foreign material on a spline was received and was sent for a fourier transform infrared spectroscopy (ft-ir) analysis.The test was ordered to confirm or rule out the type of material observed.It was concluded that the unknown fiber is principally composed of a polyacrylate base material and is widely used as thermoplastic acrylate co-polymers, in biomedicine and a variety of other advanced application areas.However, the source or origin remains unknown.The customer report was confirmed.It should be noted that product failure is multifactorial.A manufacturing record evaluation was performed for the finished device batch number 30786409l, and no internal actions related to the reported complaint were identified.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).On 09-feb-2023 it was noticed that the incorrect code was reported on the 3500a initial medwatch report # mwr-09122022-0001313881.Please consider the code of ¿environment problem identified (c15)¿ as removed from h6.Investigation findings.

• Brand Name: OCTA,LNG,48P,2-5-2-5-2,F-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: 16109513
• Report Number: 2029046-2023-00028
• Device Sequence Number: 19344103
• Product Code: MTD
• UDI-Device Identifier: 10846835021158
• UDI-Public: 10846835021158
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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,Followup
• Report Date (Section B): 03/07/2023

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 Expiration Date: 04/11/2023
• Device Model Number: D160905
• Device Catalogue Number: D160905
• Device Lot Number: 30786409L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2022
• Supplement Date Received by Manufacturer: 01/10/2023; 02/09/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 02/07/2023; 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK_OCTARAY NAV
• Patient Sex: Unknown