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
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.There was no resistance while introducing or retracting the catheter from the sheath.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
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference (b)(4) has two reports: (1) mfr # 2029046-2021-01599 for product code d128201 (pentaray nav high-density mapping catheter) (2) this report for product code d128201 (pentaray nav high-density mapping catheter).
Additional Manufacturer Narrative
Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12669537
• Report Number: 2029046-2021-01793
• Device Sequence Number: 4530718
• 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
• Report Date (Section B): 02/08/2022

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 Model Number: D128201
• Device Catalogue Number: D128201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2021
• Supplement Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 02/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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