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

Model Number	D128207
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a pentaray nav high-density mapping eco catheter and a foreign material on usable length of the catheter was observed.It was reported that there was a plastic film on one of the splines on the catheter.The physician requested a replacement of the catheter.When the catheter was replaced, the issue was resolved, and the case continued.The issue was noticed before insertion into the body.The bwi representative does not have an image of the foreign material.The material resembled a film.The plastic box was disposed of but they still have the original box and the catheter.The foreign material was the size of the spline and covered one entire spline.The device was not used on the patient.No adverse patient consequence was reported.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 4.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).
Additional Manufacturer Narrative
The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 09-sep-2022.The device evaluation was completed on 28-sep-2022.It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a pentaray nav high-density mapping eco catheter and a foreign material on usable length of the catheter was observed.It was reported that there was a plastic film on one of the splines on the catheter.The physician requested a replacement of the catheter.When the catheter was replaced, the issue was resolved, and the case continued.The issue was noticed before insertion into the body.The bwi representative does not have an image of the foreign material.The material resembled a film.The plastic box was disposed of but they still have the original box and the catheter.The foreign material was the size of the spline and covered one entire spline.The device was not used on the patient.No adverse patient consequence was reported.Device evaluation details: the pentaray nav high-density mapping eco catheter was returned to biosense webster (bwi) for evaluation.Visual inspection of the returned device was performed following bwi procedures.During the visual analysis of the returned device, foreign material was not observed, this could have been lost during the decontamination process, however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device 30805487l number, and no internal action related to the complaint was found during the review.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 reference number: (b)(4).

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• Common Device Name: 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 15344471
• Report Number: 2029046-2022-02089
• Device Sequence Number: 4529378
• Product Code: MTD
• UDI-Device Identifier: 10846835012217
• UDI-Public: 10846835012217
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K123837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2022

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 Expiration Date: 05/10/2025
• Device Model Number: D128207
• Device Catalogue Number: D128207
• Device Lot Number: 30805487L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2022
• 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: UNK BRAND CATHETER
• Patient Sex: Unknown