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

Catalog Number	D142902
Medical Device Problem Codes	Entrapment of Device (1212); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The picture was reviewed and no root cause can be determined.However, it was reported that the device is available for analysis.Therefore, once the device is received by the bwi product analysis lab, the evaluation will be performed.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 or Problem Description
It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with an optrell mapping catheter with trueref technology and the catheter got stuck in the pigtail of the impella.It was not possible to pull it out.The pigtail broke off when the impella was pulled.This can be easily removed from the iliac artery.The optrell was removed from the patient and the ablation was successfully completed.There was no patient consequence.Additional information was received.It was reported that no surgical intervention was required to remove the optrell catheter.No other device was used to remove the optrell catheter.After removing the optrell there was physical damage.
Additional Manufacturer Narrative
It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with an optrell mapping catheter with trueref technology and the catheter got stuck in the pigtail of the impella.It was not possible to pull it out.The pigtail broke off when the impella was pulled.This can be easily removed from the iliac artery.The optrell was removed from the patient and the ablation was successfully completed.There was no patient consequence.Additional information was received.It was reported that no surgical intervention was required to remove the optrell catheter.No other device was used to remove the optrell catheter.After removing the optrell there was physical damage.On 05-feb-2025, additional information was received which indicated that an impella sheath was used, and the product code and other product details are not available.Device investigation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.A visual inspection of the returned device was performed following j&j medtech procedures.Visual analysis revealed that the tip was cut from the shaft.Evidence of excessive force was observed on the shaft.The customer provided a picture where the splines were observed knotted and bent; however, the physical parts were not received.A manufacturing record evaluation was performed for the finished device number lot 31401763m and no internal action related to the complaint was found during the review.The entrapment and knotted issues reported by the customer were confirmed due to the knotted splines and broken tip.The potential cause of the knotted and broken tip could be related to the manipulation of the device during or after the procedure with the sheath; however, this could not be conclusively determined.The instructions for use of the device contain the following recommendations: do not use excessive force to advance or withdraw the catheter through the guiding sheath if resistance is encountered; do not introduce the catheter into a guiding sheath with the catheter¿s spines folded back toward the handle.Collapse the spines together using the insertion tube prior to insertion; the catheter is recommended for use with an 8.5 f guiding sheath because the spines may be damaged if used with a sheath that is not compatible.As part of johnson & johnson medtech'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 reference number: (b)(4).

• Brand Name: PTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY
• Common Device Name: 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: 21068837
• Report Number: 2029046-2025-00026
• Device Sequence Number: 11582997
• Product Code: DRF
• UDI-Device Identifier: 10846835025811
• UDI-Public: (01)10846835025811(11)240730(17)270729(10)31401763M
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K230253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: D142902
• Device Lot Number: 31401763M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 01/21/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 02/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IMPELLA DEVICE
• Patient Sex: Unknown