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

Catalog Number	D160905
Medical Device Problem Codes	Material Twisted/Bent (2981); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection, electrical, and deflection test of the returned device were performed following bwi procedures.Visual inspection was performed, and the splines were observed bent, one spline was observed with some electrodes lifted.Then, a deflection and electrical test were performed, and no issues were observed.A manufacturing record evaluation was performed for the finished device number lot and internal actions related to the complaint were found during the review.The electrical and deflection issues reported by the customer were not confirmed however, the spline damage was confirmed.The potential cause of the damage could be related to the usage of the device during procedure however, this cannot be conclusively determined.The instructions for use contain the following recommendation: do not introduce the catheter into a guiding sheath with the catheter¿s distal spines folded back toward the handle.Collapse the spines together using the insertion tube prior to insertion.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the issue of bent in the splines.Investigation findings: stress problem identified (c0706) / investigation conclusions: cause not established (d15) / component code: electrode (g0201501) were selected as related to the issue of lifted electrodes.Investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer's reported noise and deflection issues.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with an octaray mapping catheter for which biosense webster¿s product analysis lab (pal) identified electrode damage.It was initially reported by the customer there was noise on electrodes e 1 & 2 of the catheter displayed on the carto 3 system and the recording system when the catheter was inserted into the body.The caller stated that the deflection of the catheter was not working appropriately and that one of the splines of the catheter appeared to be bent.The caller stated that the catheter was unable to be fully deflected.They replaced the catheter, and the issue was resolved.There was no patient consequence.The customer¿s reported issues of noise, deflection and bent are not considered to be mdr reportable since the potential risk that these could cause or contribute to a death or serious deterioration in state of health is remote.On 3-jul-2023, the bwi pal revealed that a visual inspection of the returned device found one of the splines was observed with some electrodes lifted.This finding has been reviewed and assessed as an mdr reportable malfunction.

• Brand Name: OCTARAY 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17401765
• Report Number: 2029046-2023-01605
• Device Sequence Number: 14124873
• Product Code: MTD
• UDI-Device Identifier: 10846835021158
• UDI-Public: 10846835021158
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• 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: 06/19/2023
• Device Catalogue Number: D160905
• Device Lot Number: 30839457L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2023
• Initial Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2022
• 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: CARTO 3 SYSTEM; OCTA,LNG,48P,2-5-2-5-2,F-CURVE; UNKNOWN RECORDING SYSTEM
• Patient Sex: Unknown