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

Catalog Number D142901

Device Problem Coagulation in Device or Device Ingredient (1096)

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

Event Date 10/18/2023

Event Type  malfunction  

Manufacturer Narrative

E 1.Initial reporter phone : (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 31120178m and no internal action related to the complaint was found during the review.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 Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with an optrell mapping catheter with trueref technology and when the sheath was replaced, a thrombus was found adhered to the catheter on the ¿paddle part¿.The thrombus was removed, and the procedure was continued.No adverse patient consequence was reported.Additional information was received, and it was reported that the patient was anticoagulated.Activated coagulation time (act)was 300 seconds over.Heparinized normal saline was used.

Manufacturer Narrative

Additional information was received on (b)(6) 2023.It was reported that ablation was performed with a thermocool® smart touch® sf (stsf) catheter.As such, the concomitant product section was updated.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
• 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: 18136682
• MDR Text Key: 328281946
• Report Number: 2029046-2023-02640
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835025828
• UDI-Public: 10846835025828
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K230253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

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 Catalogue Number: D142901
• Device Lot Number: 31120178M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/19/2023
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 11/28/2023
• Supplement Dates FDA Received: 12/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2023
• 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: NGEN PUMP, JAPAN CONFIGURATION; NGEN RF GENERATOR, JAPAN; UNK BRAND SHEATH; UNK THERMOCOOL® SMART TOUCH® SF CATHETER; UNK_CARTO 3