MAUDE Adverse Event Report: BIOSENSE WEBSTER INC AVAIL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	F6QRD010RT
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrioventricular re-entry tachycardia (avrt) and a wolff-parkinson-white (wpw) ablation procedure with an avail¿ electrophysiology catheter wherein sterilization of the device was compromised.It was reported that a worm was observed on the seal of primary package; the pouch was not opened.A second catheter was used to complete the operation.There was no patient consequence.This complaint will be conservatively reported as even though the worm is on the outer seal which does not compromise sterility, however, it was determined that once the package was opened, the worm would compromise sterility.
Additional Manufacturer Narrative
If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Additional Manufacturer Narrative
On 17-mar-2022, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.# (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrioventricular re-entry tachycardia (avrt) and a wolff-parkinson-white (wpw) ablation procedure with an avail¿ electrophysiology catheter wherein sterilization of the device was compromised.It was reported that a worm was observed on the seal of primary package; the pouch was not opened.A second catheter was used to complete the operation.There was no patient consequence.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Bwi conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that no foreign material was observed inside the primary package.However, the customer provided a photo of the complaint issue to aid in the investigation.According to the photo provided by the customer, pouch was observed closed and the foreign material was observed outside the internal seal.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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.The instructions for use contain the following recommendations: store in a cool, dry place.The sterile packaging and catheter should be inspected prior to use.The photo was reviewed with the manufacturing process team, and no further investigation was required since the worm was observed out of the pouch seal.It was determined that the reported condition could not be assignable to the manufacturing process (packaging).All the control points, inspections, and executions were found correctly executed.The customer complaint was confirmed based on the picture received.However, with the information available, it can be concluded that the issue occurred outside the manufacturing environment.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: AVAIL¿ ELECTROPHYSIOLOGY CATHETER
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13717838
• Report Number: 2029046-2022-00502
• Device Sequence Number: 11918074
• Product Code: DRF
• UDI-Device Identifier: 10846835000528
• UDI-Public: 10846835000528
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K892265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2022

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 Expiration Date: 08/18/2024
• Device Model Number: F6QRD010RT
• Device Catalogue Number: F6QRD010RT
• Device Lot Number: 30626589L
• 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: 02/13/2022
• Supplement Date Received by Manufacturer: 03/17/2022; 05/13/2022
• Initial Report FDA Received Date: 03/10/2022
• Supplement Report FDA Received Date: 03/28/2022; 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2021
• 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: FIX 6F,4P,D,10MM,PU,10PN-LPFR
• Patient Sex: Unknown