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

Catalog Number D140901

Device Problem Device-Device Incompatibility (2919)

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

Event Date 06/07/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with an optrell mapping catheter with trueref technology for which biosense webster¿s product analysis lab (pal) identified the transition of the tip with the splines was broken exposing internal parts.It was initially reported the optrell mapping catheter with trueref technology would not advance into the sl1 abbott sheath.Caller stated the physician had to use a different type/brand of sheath in order to advance the catheter.When the sheath and the catheter was replaced, the issue resolved.The customer¿s reported issue of resistance with the sheath is not considered to be mdr reportable since an increased potential for patient injury is remote.On 13-sep-2023, the bwi pal revealed that a visual inspection of the returned device found the transition of the tip with the splines was broken exposing internal parts.This finding was reviewed and assessed as an mdr reportable malfunction.

Manufacturer Narrative

Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and functional test of the returned device were performed following bwi procedures.Visual analysis revealed in the transition of the tip with the splines, it was found broken with exposed internal parts.Also, the introducer was found torn.A dimensional test was performed, and the outer diameters of the device were found within specifications.The damage on the tip and on the introducer suggests that a resistance with sheath event took place, however, this could not be conclusively determined as no issues were detected during the dimensional inspection.Based on the damage observed the issue described by the customer was confirmed.All units are inspected prior to leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.A manufacturing record evaluation was performed for the finished device and no internal actions related to the complaint were found during the review.The resistance issue reported by the customer was confirmed.The instructions for use contain (ifu) the following recommendations: do not introduce the catheter into a guiding sheath with the catheter¿s distal spines folded backward toward the handle.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 17870725
• MDR Text Key: 324922461
• Report Number: 2029046-2023-02229
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835023015
• UDI-Public: 10846835023015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211438
• 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
• Report Date: 10/04/2023

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 Expiration Date: 09/01/2023
• Device Catalogue Number: D140901
• Device Lot Number: 30904792M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2022
• 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: SL1 ABBOTT SHEATH