MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OCTARAY, GALAXY, 48P, 3-3-3-3-3, D-CURVE; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D160903

Device Problems Break (1069); Contamination /Decontamination Problem (2895); Device-Device Incompatibility (2919)

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

Event Date 03/01/2023

Event Type  malfunction  

Manufacturer Narrative

The product has not returned for analysis, however, a picture was provided by the customer.Evaluation is still in progress.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.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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with an octaray, galaxy, 48p, 3-3-3-3-3, d-curve, and a broken tip and foreign material on usable length of catheter issue occurred.It was reported that after the initial bipolar map of the left atrium, the ocataray catheter was removed.Upon removing the catheter from the patient, the physician noticed physical damage to the octaray catheter.The damage was located on one of the splines.It was stated that "it looks like an exposed puller wire".The damage did not result in any lifted or sharp rings.There was resistance in removing the catheter until the splines were back in the sheath.The catheter was not pre-shaped.The catheter was exchanged, and the case was continued.No adverse patient consequence was reported.Additional information was received on 03-mar-2023.There was no insertion tool used during the procedure, only the introducer sleeve provided with the octaray.A clear, thin, flat plastic material was observed after the catheter was removed from the patient¿s body.This material was not attached to the catheter, but separate.The resistance with sheath is not mdr reportable.The broken tip and foreign material on usable length of the catheter were assessed as mdr reportable to the fda.

Manufacturer Narrative

The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 05-apr-2023.The device evaluation was completed on 13-apr-2023.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with an octaray, galaxy, 48p, 3-3-3-3-3, d-curve, and a broken tip and foreign material on usable length of catheter issue occurred.Device evaluation details: according to the picture provided by the customer, a spline of the octaray catheter was observed with a bent condition.No other damages or anomalies were observed on the octaray catheter.Also, a plastic thread was observed, however, additional information revealed that this material was not originally attached to the device.The device was returned to biosense webster (bwi) for evaluation.A visual inspection and dimensional test of the returned device were performed following bwi procedures.Visual analysis revealed a bent spline and two electrodes damaged (lifted).No other anomalies were observed.In addition, according to the provided picture by the customer, foreign material was observed; however, this material was not returned.A dimensional test was performed, and outer diameters of the device were found within specifications.The physical damage observed could be related to the wrong manipulation of the catheter with the insertion tool causing the resistance with the sheath; however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device 30955013l number, and no internal actions related to the reported complaint condition were identified.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instructions of use contain the following recommendation: the catheter is recommended for use with an 8f guiding sheath because the distal spines may be damaged if used with a sheath that is not compatible.Do not use the catheter in conjunction with transseptal sheaths featuring side holes larger than 1.25mm in diameter.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi¿s quality system.Explanation of codes: investigation findings: mechanical problem identified (c07)/investigation conclusions: unintended use error caused or contributed to event (d1102))/component code: tip (g04129) were selected as related to the bent spline.Investigation findings: stress problem identified (c0706)/investigation conclusions: unintended use error caused or contributed to event (d1102))/component code: electrode (g0201501) were selected as related to the electrode damage.Investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported broken tip and foreign material.H6.Investigation findings code of "appropriate term/code not available" represents photo/video analysis.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, 3-3-3-3-3, D-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: 16636670
• MDR Text Key: 312502756
• Report Number: 2029046-2023-00670
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835021127
• UDI-Public: 10846835021127
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

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
• Device Operator: Health Professional
• Device Model Number: D160903
• Device Catalogue Number: D160903
• Device Lot Number: 30955013L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/29/2023
• Supplement Dates Manufacturer Received: 04/05/2023
• Supplement Dates FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2022
• 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: OCTA,LNG,48P,3-3-3-3-3,D-CURVE; UNK BAYLIS VERSACROSS NON-STEERABLE SHEATH