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

Model Number F6QRD010RT

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2022

Event Type  malfunction  

Event 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.

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).

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).

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
• Type of Device: 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
• MDR Text Key: 290469957
• Report Number: 2029046-2022-00502
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835000528
• UDI-Public: 10846835000528
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K892265
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 02/13/2022
• Initial Date FDA Received: 03/10/2022
• Supplement Dates Manufacturer Received: 03/17/2022; 05/13/2022
• Supplement Dates FDA Received: 03/28/2022; 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FIX 6F,4P,D,10MM,PU,10PN-LPFR