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

Model Number	D160902
Medical Device Problem Codes	Partial Blockage (1065); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone: (b)(6).Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial tachycardia ablation procedure with a octaray, galaxy, 48p, 2-5-2-5-2, d-curve and a clot on the catheter was observed.During the procedure, the octaray catheter was noted to have clot formation at the lumen and did not irrigate sufficiently.The activated clotting time (act) was maintained at 360 throughout the procedure, and irrigation was confirmed on the octaray catheter before insertion into the body.Upon noticing the clot, the physician took a new catheter to complete the procedure.There was no patient impact and the procedure was not delayed.
Additional Manufacturer Narrative
The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 30-may-2022.The device evaluation was completed on 06-jun-2022.It was reported that a patient underwent an atrial tachycardia ablation procedure with a octaray, galaxy, 48p, 2-5-2-5-2, d curve and a clot on the catheter was observed.During the procedure, the octaray catheter was noted to have clot formation at the lumen and did not irrigate sufficiently.The activated clotting time (act) was maintained at 360 throughout the procedure, and irrigation was confirmed on the octaray catheter before insertion into the body.Upon noticing the clot, the physician took a new catheter to complete the procedure.There was no patient impact and the procedure was not delayed.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation.Bwi conducted a visual inspection and functional test of the returned device.The device was inspected, and no physical damage was found.A clot was found on the tip area in the returned octaray nav.Patency testing was performed in accordance with bwi procedures.A patency test was performed, per bwi procedures.The catheter failed the test since the irrigation tube was occluded with reddish-brown material at the tip, which could be dried blood.This condition could be related to the irrigation issue.The instructions for use contain the following instruction: the tip electrodes must be inspected for coagulum/ clots.Remove any coagulum/ clots with a sterile gauze pad dampened with sterile saline.It also contains the following precautions: flush the catheter with heparinized saline prior to insertion into the body.A manufacturing record evaluation was performed for the finished device number 30667005l, and no internal actions related to the complaint were found during the review.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, D-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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 14079845
• Report Number: 2029046-2022-00778
• Device Sequence Number: 5276413
• Product Code: MTD
• UDI-Device Identifier: 10846835021110
• UDI-Public: 10846835021110
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/12/2022
• Device Model Number: D160902
• Device Catalogue Number: D160902
• Device Lot Number: 30667005L
• 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: 03/14/2022
• Supplement Date Received by Manufacturer: 05/30/2022
• Initial Report FDA Received Date: 04/11/2022
• Supplement Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2021
• 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: UNK BRAND CATHETER
• Patient Sex: Unknown