MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OCTARAY, GALAXY, 48P, 2-5-2-5-2, F-CURVE; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number	D160905
Medical Device Problem Codes	Mechanical Jam (2983); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that an unknown patient underwent an afib - paroxysmal ablation procedure with a octaray, galaxy, 48p, 2-5-2-5-2, f-curve.It was reported that the octaray catheter lost deflection during the procedure and was stuck at an 80 degree curve.The catheter was replaced, and the issue resolved.The case continued without further incident or harm.The curve of the catheter was stuck/jammed in a full deflected position.The knob/piston was not unable to be turned and/or pushed up and down, you could still move plunger hanger, but curve would not release.There was no difficulty in removing the catheter.There was no ring, electrode or other physical damage observed at the distal end of the catheter.They have already sent device back, so they do not have images.The sheath used was a 8f long.Deflection issue is not mdr-reportable.Deflection stuck is mdr-reportable.
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).
Additional Manufacturer Narrative
The product investigation was updated on 04-jul-2023 as follows: visual inspection and deflection test of the returned device were performed following biosense webster inc.(bwi) procedures.Visual analysis revealed that the handle deflection was stuck, it did not come back to fully relaxed position.Manufacturing investigation concluded the reported condition is manufacture related since the catheter were over adjusted a manufacturing record evaluation was performed for the finished device, and no internal actions related to the reported complaint condition were identified.The deflection issue reported by the customer was confirmed.Other issues or circumstances may have occurred during the usage of the device that compromised its performance.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 ref.# (b)(4).During an internal review on 28-jun-2023, it was noted that the medical device problem code of positioning problem (a1502) was not necessary as the code of mechanical jam (a0506) is sufficient in categorizing the event.Therefore, the code of positioning problem (a1502) was removed.
Additional Manufacturer Narrative
It was reported that an unknown patient underwent an afib - paroxysmal ablation procedure with a octaray, galaxy, 48p, 2-5-2-5-2, f-curve.It was reported that the octaray catheter lost deflection during the procedure and was stuck at an 80 degree curve.The curve of the catheter was stuck/jammed in a full deflected position.The catheter was replaced, and the issue resolved.The case continued without further incident or harm.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation.Visual inspection and deflection test of the returned device was performed following bwi procedures and the evaluation was completed.Visual analysis revealed that the handle deflection was stuck, it did not come back to fully relaxed position.Manufacturing investigation concluded the reported condition is manufacture related since the catheter were overly tight.As part of the investigation process, it was determined that pre-curve condition was produce by an over adjustment of the set screw.No procedural /design modifications are recommended per the incidence / harm rate.Awareness will be given to all personnel.A manufacturing record evaluation was performed for the finished device, and no internal actions related to the reported complaint condition were identified.The deflection issue reported by the customer was confirmed other issues or circumstances may have occurred during the usage of the device that compromised its performance.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 ref.# (b)(4).

• Brand Name: OCTARAY, GALAXY, 48P, 2-5-2-5-2, F-CURVE
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16017876
• Report Number: 2029046-2022-03200
• Device Sequence Number: 17827197
• Product Code: MTD
• UDI-Device Identifier: 10846835021158
• UDI-Public: 10846835021158
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K193237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/26/2023

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: 03/04/2023
• Device Model Number: D160905
• Device Catalogue Number: D160905
• Device Lot Number: 30747871L
• 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: 11/29/2022
• Supplement Date Received by Manufacturer: 01/03/2023; 05/26/2023; 06/28/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 01/27/2023; 06/23/2023; 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2022
• 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: UNSPECIFIED 8F LONG SHEATH
• Patient Sex: Unknown