MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number D140901

Device Problems Contamination /Decontamination Problem (2895); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a optrell mapping catheter with trueref technology and a foreign material was found on the device.It was reported that after the optrell catheter was removed from the body, after the procedure, a kink was noticed in one of the splines.The caller also reported that electrode f2 had some foreign debris on it.The caller reported that the debris appeared to be "lint" or a small piece of metal.There was no resistance and no patient consequence.

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 ref.# (b)(4).

Manufacturer Narrative

On 9-aug-2023, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

On (b)(6) 2023, additional information was received indicating a carto vizigo sheath was used in the case.The item has been added to the concomitant product section.Device investigation details: a picture was received for analysis, and evaluated following biosense webster's procedures.According to the picture provided, an electrode was observed lifted with sharp edges.No internal components exposed were observed.Also, a small debris is observed in the electrode.A manufacturing record evaluation was performed, and no internal action related to the reported complaint were identified.The customer complaint was confirmed based on the picture received.The device has not been returned for analysis, and a root cause cannot be assigned based on the current evidence.If the device is received in the future, the product investigation will be performed and updated accordingly, and any action will be taken if necessary.Explanation of codes from picture analysis: investigation findings: stress problem identified (c0706) / investigation conclusions: cause not established (d15) / component code: electrode (g0201501) were selected as related to the issue of lifted sharp electrode.Investigation findings: inappropriate material (c0602) / investigation conclusions: cause not established (d15) were selected as related to the customer's reported foreign material issue.Note: h6.Investigation findings code of ¿appropriate term/code not available (c22)¿ used to represent the photo analysis results.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) correction: it was noticed the following information was inadvertently omitted from section h10 of the 3500a initial medwatch report.¿the product has not returned for analysis, however, a picture was provided by the customer.Evaluation is still in progress.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.¿.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a optrell mapping catheter with trueref technology and a foreign material was found on the device.It was reported that after the optrell catheter was removed from the body, after the procedure, a kink was noticed in one of the splines.The caller also reported that electrode f2 had some foreign debris on it.The caller reported that the debris appeared to be "lint" or a small piece of metal.There was no resistance and no patient consequence.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection evaluation of the returned device was performed following bwi procedures.Visual analysis of the returned sample revealed that one of the splines was bent and also, a foreign material was attached to one of the electrodes.According to the picture provided, an electrode lifted was observed; however, during the physical analysis, no damage on the electrode was found.For this reason, a fourier-transform infrared spectroscopy (ft-ir) analysis was requested.The analysis concluded that the transparent foreign material found on the electrodes is mainly composed of polytetrafluoroethylene (ptfe) based material with different degrees of polymerization.The source of origin cannot be ascertained.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer was confirmed.The root cause of the bent condition could be related to the manipulation of the device during the procedure; however, this cannot be conclusively determined.It should be noted that product failure is multifactorial.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the issue of bent spline.Investigation findings: inappropriate material (c0602) / investigation conclusions: cause not established (d15) / component code: electrode (g0201501) were selected as related to the customer's foreign material.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 17088610
• MDR Text Key: 316848951
• Report Number: 2029046-2023-01258
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835023015
• UDI-Public: 10846835023015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/01/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 08/17/2023
• Device Model Number: D140901
• Device Catalogue Number: D140901
• Device Lot Number: 30882504M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 06/08/2023
• Supplement Dates Manufacturer Received: 06/20/2023; 08/09/2023; 08/28/2023
• Supplement Dates FDA Received: 07/12/2023; 08/14/2023; 09/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2022
• 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
• Treatment: UNK_CARTO VIZIGO SHEATH.