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

Catalog Number	D140901
Medical Device Problem Codes	Obstruction of Flow (2423); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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).
Event or Problem Description
It was reported that a patient underwent an atrial fibrilation (afib) procedure with an optrell mapping catheter with trueref technology and an irrigation issue (used in the patient) occurred.During the procedure, as they were finishing using the optrell mapping catheter with trueref technology, the physician stated they heard the irrigation for the optrell mapping catheter with trueref technology break.At this point, they were finished with the optrell mapping catheter with trueref technology, so they removed it from the patient's body and continued with the procedure.There was no patient consequence reported.Additional information was received.The physical irrigation port broke.The irrigation port broke was assessed as non mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The irrigation issue (used in the patient) was assessed as mdr reportable.
Additional Manufacturer Narrative
The investigation was completed on (b)(6) 2024.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 31121964m number, and no internal action related to the complaint was found during the review.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
It was reported that a patient underwent an atrial fibrilation (afib) procedure with an optrell mapping catheter with trueref technology.During the procedure, as they were finishing using the optrell mapping catheter with trueref technology, the physician stated they heard the irrigation for the optrell mapping catheter with trueref technology break.At this point, they were finished with the optrell mapping catheter with trueref technology, so they removed it from the patient's body and continued with the procedure.There was no patient consequence reported.Additional information was received.The physical irrigation port broke.The bwi product analysis lab received the device for evaluation 23-apr-2024.The device evaluation was completed on 30-apr-2024.The device was returned to biosense webster (bwi) for evaluation.Visual inspection and patency test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The luer hub valve was reviewed in detail and no issues were identified.Then a patency test was performed, and the catheter failed the test since the irrigation tube was found folded at the tip section.A manufacturing record evaluation was performed and no internal actions related to the reported complaint condition were identified.The irrigation issue reported by the customer was confirmed.The potential cause of the folded irrigation tubing cannot be determined.In the other hand, the luer hub issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instructions for use contain the following warnings and precautions: purge the catheter and the irrigation tubing with heparinized normal saline prior to insertion of the catheter into the patient.Inspect the irrigation saline for air bubbles prior to its use in the procedure.Air bubbles in the irrigation saline may cause emboli.Always maintain a constant heparinized normal saline infusion to prevent coagulation within the lumen of the catheter.Do not use the catheter without irrigation flow.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.Explanation of codes: -investigation findings: no device problem found (c19)/ investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿physical irrigation port broke " issue.-investigation findings: operational problem identified (c13)/ investigation conclusions: cause not established (d15) / component code: hose (g04069) were selected as related to the customer¿s reported ¿irrigation¿ issue.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: OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY
• Common Device Name: 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: 18543338
• Report Number: 2029046-2024-00229
• Device Sequence Number: 12743332
• Product Code: DRF
• UDI-Device Identifier: 10846835023015
• UDI-Public: 10846835023015
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K211438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2024

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: 08/01/2024
• Device Catalogue Number: D140901
• Device Lot Number: 31121964M
• 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: 12/21/2023
• Supplement Date Received by Manufacturer: 01/23/2024; 04/23/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 02/14/2024; 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2023
• 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