MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D128211

Device Problems Entrapment of Device (1212); Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 04/20/2023

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter phone: (b)(4).H6.Medical device problem code of ¿appropriate term/code not available (a27)¿ represents patient event non serious.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 Description

It was reported that a patient underwent a premature ventricular contraction ablation procedure with a pentaray nav high-density mapping eco catheter.It was reported that the procedure was the ablation procedure for premature ventricular contraction.When attempting to place the pentaray nav high-density mapping eco catheter in the right ventricular outflow tract, the catheter got caught and stuck with the chorda tendinea.The pentaray nav high-density mapping eco catheter spine appeared to be twisted on the carto screen.After removal of the catheter, a piece of patient¿s tissue was found on the catheter.Timing was after 10 minutes use of the catheter.After the catheter removal, the procedure was completed successfully.No cardiac dysfunctions were found on the right ventriculogram and echocardiogram.Physician's comment on the relationship between this event and the product was there were no abnormalities with the pentaray nav high-density mapping eco catheter.There was no abnormality before using the product.There was an abnormality while using the product.Additional information was received.There was a patient consequence.After the pentaray nav high-density mapping eco catheter was stuck in the chordae tendineae, tissue pieces were attached to the removed catheter, and therefore it was considered that the chordae tendineae of the patient was ruptured and a part of the chordae tendineae tissue was removed from the body.No particular treatment was required because cardiac dysfunction was not observed when confirmed by right ventriculography and echocardiography.The patient event was assessed as non reportable as non serious.Since it was not life threatening; does not result in permanent impairment of a body function or permanent damage to a body structure; or does not necessitate medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.The entrapment issue was assessed as mdr reportable for a medical device entrapment with excessive manipulation required issue.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 14-jun-2023.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a premature ventricular contraction ablation procedure with a pentaray nav high-density mapping eco catheter.It was reported that the procedure was the ablation procedure for premature ventricular contraction.When attempting to place the pentaray nav high-density mapping eco catheter in the right ventricular outflow tract, the catheter got caught and stuck with the chorda tendinea.The pentaray nav high-density mapping eco catheter spine appeared to be twisted on the carto screen.After removal of the catheter, a piece of patient¿s tissue was found on the catheter.Timing was after 10 minutes use of the catheter.After the catheter removal, the procedure was completed successfully.No cardiac dysfunctions were found on the right ventriculogram and echocardiogram.Physician's comment on the relationship between this event and the product was there were no abnormalities with the pentaray nav high-density mapping eco catheter.There was no abnormality before using the product.There was an abnormality while using the product.The device evaluation was completed on 20-jun-2023.The device was returned to biosense webster (bwi) for evaluation.A visual inspection and functional test of the returned device were performed following bwi procedures.Visual analysis revealed that some of the spines of the device were bent.A dimensional test was performed, and the outer diameters of the device were found within specifications.The failure observed on the spines could be related to the excessive force on the handling of the device during the procedure; however, this can not be conclusively determined.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 as the damage observed on the spines could be related to the issue reported.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.This product issue will be addressed through bwi¿s quality system.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(6).

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• Type of Device: 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: 16961950
• MDR Text Key: 315573254
• Report Number: 2029046-2023-01087
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30972204L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2022
• 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 3.