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

Catalog Number	D160905
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) paroxysmal ablation procedure with a octaray, galaxy, 48p, 2-5-2-5-2, f-curve.After the end of the procedure, octaray was removed from the patient and a large thrombus was attached to the catheter.The activated clotting time (act) was in therapeutic level the whole time octaray was present in the left atrium (la).The octaray and the sheath was flushed with heparinised saline.A pressure bag was attached to the octaray flush.The flush was not obstructed.No ablation was performed on or close to the octaray.No patient consequences were reported.
Additional Manufacturer Narrative
The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.However, a picture was received for evaluation following biosense webster's procedures.Device investigation details: according to pictures provided by the customer, a thrombus was observed attached to the tip on a electrode.A manufacturing record evaluation was performed for finished device number 31077671l, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed based on the picture received.Manufacturer's reference number: (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: 18024835
• Report Number: 2029046-2023-02465
• Device Sequence Number: 7593996
• Product Code: MTD
• UDI-Device Identifier: 10846835021158
• UDI-Public: 10846835021158
• Combination Product (Y/N): N
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/27/2023

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: 05/30/2024
• Device Catalogue Number: D160905
• Device Lot Number: 31077671L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2023
• 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
• Patient Sex: Unknown