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

Catalog Number D128211

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017); Contamination /Decontamination Problem (2895)

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

Event Date 09/22/2023

Event Type  malfunction  

Manufacturer Narrative

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.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).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter and a piece of the device had come off and was hanging on the side of the spline.It was reported by the caller, a bwi representative, that after taking the catheter out of the body, a piece of the pentaray nav high-density mapping eco catheter had come off and was hanging on the side of the spline.There was no difficulty experienced with maneuvering the catheter or during withdrawal.The issue was noticed after withdrawing the pentaray nav high-density mapping eco catheter so an ¿stsf¿ could be inserted through the same sheath.The sheath was a medtronic flexcath advance which is a 12 french sheath.The catheter was replaced and the issue was resolved.The case continued.There was no patient consequence.It was also reported that after talking with the scrub tech following the case, she let us know that the doctor inserted the pentaray nav high-density mapping eco catheter without using the introducer which may account for the damage.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter and a piece of the device had come off and was hanging on the side of the spline.It was reported by the caller, a bwi representative, that after taking the catheter out of the body, a piece of the pentaray nav high-density mapping eco catheter had come off and was hanging on the side of the spline.There was no difficulty experienced with maneuvering the catheter or during withdrawal.The issue was noticed after withdrawing the pentaray nav high-density mapping eco catheter so an ¿stsf¿ could be inserted through the same sheath.The sheath was a medtronic flexcath advance which is a 12 french sheath.The catheter was replaced and the issue was resolved.The case continued.There was 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 of the returned device were performed following bwi procedures.Visual analysis revealed that one spline has a small damage electrode.The electrode was observed dent and partially lifted, no internal components were exposed.No other issues were observed during the visual inspection.In other hand, and according to pictures provided by the customer, a plastic hair-like string was discovered attached to the splines of the pentaray catheter.The transparent foreign material reported on the electrode could be related to the used sheath during the procedure, however, this cannot 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.It should be noted that product failure is multifactorial.Even though the foreign material reported by the customer was not returned for analysis, the damage electrode could cause the reported event.Inserting a catheter with a partially lifted electrode into a sheath could trigger the issue reported by the customer.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: stress problem identified (c0706) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the spline damage.Investigation findings: inappropriate material (c0602) / investigation conclusions: known inherent risk of device (d12) were selected as related to the identified plastic hair-like string that was discovered.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 product received date was inadvertently omitted from the 3500a initial mdr.As such, section d has been appropriately updated.

• 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: 17971596
• MDR Text Key: 326479483
• Report Number: 2029046-2023-02385
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123837
• 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
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D128211
• Device Lot Number: 31111357L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2023
• 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: MEDTRONIC FLEXCATH ADVANCE