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

Model Number	D128201
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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
During an animal study sponsored by biosense webster inc., (bwi) r&d, while using a pentaray nav high-density mapping catheter, it was reported that a foreign material ¿ on usable length of the catheter issue occurred.It was reported that when the pentaray catheter was removed from sheath, it was noticed that the catheter had a lot of "yellowish, white fibrous plastic material" tangled on the splines of the catheter.It was noted that the material did not appear to be biological.It was reported that the animal study had been completed at this point, and no replacement catheter was needed.No human patient involvement.
Additional Manufacturer Narrative
The biosense webster, inc.Product analysis lab received the device for evaluation.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on 28-sep-2021, it was noted that a second pentaray catheter should have been added as a concomitant product on the initial report.Therefore, the concomitant product section has been updated on this report.Also, additional information was received on 14-sep-2021 that was inadvertently omitted on the initial report.It was reported that there was no resistance while introducing or retracting the catheter from the sheath.
Additional Manufacturer Narrative
The device evaluation was completed on (b)(6)-2021.During an animal study sponsored by biosense webster inc., (bwi) r&d, while using a pentaray nav high-density mapping catheter, it was reported that a foreign material ¿ on usable length of the catheter issue occurred.It was reported that when the pentaray catheter was removed from sheath, it was noticed that the catheter had a lot of "yellowish, white fibrous plastic material" tangled on the splines of the catheter.It was noted that the material did not appear to be biological.It was reported that the animal study had been completed at this point, and no replacement catheter was needed.No human patient involvement.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation.Bwi conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the pentaray nav high-density mapping catheter.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.Initially, the lot number was reported as unknown.However, during the investigational analysis of the returned device, the lot number was able to be retrieved.Therefore, d4.Lot, d 4.Expiration date, and h 4.Device manufacture date fields were populated on this report.A manufacturing record evaluation was performed for the finished device 30592996l number, and no internal actions related to the reported complaint condition were identified.The event described could not be confirmed as the device was found in good conditions.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.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 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 ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12501908
• Report Number: 2029046-2021-01599
• Device Sequence Number: 3788046
• Product Code: MTD
• UDI-Device Identifier: 10846835009576
• UDI-Public: 10846835009576
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120425
• 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,Followup
• Report Date (Section B): 11/12/2021

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: 06/23/2024
• Device Model Number: D128201
• Device Catalogue Number: D128201
• Device Lot Number: 30592996L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 09/27/2021; 10/20/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 09/28/2021; 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2021
• 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: ABBOTT ST JUDE AGILIS 8.5FR SHEATH; PENTARAY NAV, 7FR, F, 4-4-4
• Patient Sex: Unknown