BIOSENSE WEBSTER INC OCTA,LNG,48P,2-5-2-5-2,F-CURVE; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
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Model Number D160905 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2022 |
Event Type
malfunction
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Event Description
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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.
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Manufacturer Narrative
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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).
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Manufacturer Narrative
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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).
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Manufacturer Narrative
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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.
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