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

Device Problems Contamination (1120); Entrapment of Device (1212)

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

Event Date 01/26/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an unknown ablation procedure with a octaray, galaxy, 48p, 2-5-2-5-2, f-curve.It was reported that when manipulating the octaray catheter to access the right ventricle, it appeared to get stuck on the tricuspid annulus.The operator could feel resistance when attempting to move the catheter.Upon further inspection using an ice (intracardiac echocardiography) catheter it was found that one or more splines seemed to be entangled on the medial septal tricuspid annulus.Eventually after 30 plus minutes of manipulating the catheter in an attempt to free it, it was dislodged and able to be pulled out of the body.Inspection of the catheter once it was pulled out showed a small amount of tissue wrapped around one of the splines.The product was not used in a clinical trial.Catheter was eventually removed from the body.There was a patient impact, and the procedure was extended greater than 30 minutes due to the delay.There was potential minor damage to the patient¿s valve.This was indicated by the small amount of tissue that was wrapped around an octaray spline upon removal from the patient¿s body.The event is being reported as an adverse event.This also delayed the procedure for greater than 30 minutes.No bleeding reported.No patient consequence.Sheath was a abbott agilis 8.5f steerable sheath.Duration of the delay was approx.45-60 min.In physician¿s opinion, the delay did not contribute to a death or a serious injury to the patient.No intervention required.No other issues noted.Medical device entrapment with excessive manipulation required is mdr-reportable.Biological material is not mdr-reportable.

Manufacturer Narrative

Initial reporter phone: (b)(6).The bwi 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.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).

Manufacturer Narrative

On 13-mar-2023, the product investigation was completed.It was reported that a patient underwent an unknown ablation procedure with a octaray, galaxy, 48p, 2-5-2-5-2, f-curve.It was reported that when manipulating the octaray catheter to access the right ventricle, it appeared to get stuck on the tricuspid annulus.The operator could feel resistance when attempting to move the catheter.Upon further inspection using an ice (intracardiac echocardiography) catheter it was found that one or more splines seemed to be entangled on the medial septal tricuspid annulus.Eventually after 30 plus minutes of manipulating the catheter in an attempt to free it, it was dislodged and able to be pulled out of the body.Inspection of the catheter once it was pulled out showed a small amount of tissue wrapped around one of the splines.Device investigation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection and dimensional inspection of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.No sign of tissue was observed.A dimensional test was performed, and outer diameters of the device were found within specifications.A manufacturing record evaluation was performed for the finished device [30846891l] number, and no internal actions related to the reported complaint condition were identified. the issue reported by the customer could not be confirmed during the product investigation; 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 reference number: (b)(4).

• Brand Name: OCTARAY, GALAXY, 48P, 2-5-2-5-2, F-CURVE
• Type of Device: 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: 16440183
• MDR Text Key: 310372844
• Report Number: 2029046-2023-00385
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835021158
• UDI-Public: 10846835021158
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K193237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: D160905
• Device Catalogue Number: D160905
• Device Lot Number: 30846891L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2022
• 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: ABBOTT AGILIS; QDOT MICRO; WEBSTER CS CATHETER