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

Catalog Number D160902

Device Problem Signal Artifact/Noise (1036)

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

Event Date 01/24/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with an octaray mapping catheter for which biosense webster¿s product analysis lab (pal) identified that the shaft was broken exposing internal wires.Initially, it was reported that when the octaray was connected and immediately inserted into the patient¿s body, noise occurred.Re-connecting and replacing the cable did not resolve the issue.The catheter was replaced.Though the noise remained on some electric potentials a little, the physician determined no problem, so the procedure was continued.The procedure was completed without patient consequence.The signal noise issue was assessed as non mdr reportable.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 07-mar-2024, shaft was broken exposing internal wires.This was assessed as mdr reportable.The awareness date for this reportable lab finding was 07-mar-2024.

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).The product was returned to biosense webster (bwi) for evaluation.A visual inspection and electrical evaluation of the returned device were performed following bwi procedures.Visual analysis revealed that the device shaft was broken exposing internal wires.The root cause of the damage could be related to the shipping/ handling; however, this cannot be conclusively determined.An electrical test was performed, and current leakage with several open circuits were detected due to the damage in the shaft.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.A manufacturing record evaluation was performed for the finished device number 31124103l, and no internal action was found during the review.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.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).

• Brand Name: OCTARAY MAPPING 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: 19030089
• MDR Text Key: 339237533
• Report Number: 2029046-2024-01119
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835021110
• UDI-Public: 10846835021110
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K193237
• 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
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D160902
• Device Lot Number: 31124103L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2024
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: OCTA,LNG,48P,2-5-2-5-2,D-CURVE; SMARTABLATE GEN. KIT (JAPAN); THMCL SMTCH SF BID, TC, D-D; UNK BRAND CABLE; UNK BRAND CABLE; UNK_CARTO 3
• Patient Sex: Male
• Patient Weight: 53 KG