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

Model Number D160901

Device Problem Material Deformation (2976)

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

Event Date 11/17/2022

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 08-dec-2022.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.Biosense webster manufacturer's reference number: (b)(4) has two complaints that are related to the same incident.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with an octaray, perseid, 48p, 2-2-2-2-2, d-curve and an electrode damaged with foreign material issue occurred.In addition, the carto vizigo¿ 8.5f bi-directional guiding sheath ¿medium had a leak on the stop cock.During the procedure when mapping, the ultrasound showed that something was on the catheter.They explained that "when they pulled back on the sheath and pulled the catheter out, they found a metallic fiber coming off of one of the splines." it looked like "some sort of internal wiring of one of the electrodes." to troubleshoot , they replaced the catheter.The issue was resolved and the procedure continued.Additional information was received.During the procedure a carto vizigo¿ 8.5f bi-directional guiding sheath - medium was being used.They are requesting an investigation for the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium as well.Physician reported that the side port of the carto vizigo¿ 8.5f bi-directional guiding sheath - medium was leaking at the end of the case.Physician also reported that it was difficult to advance the octaray, perseid, 48p, 2-2-2-2-2, d-curve.Photos were provided.There was lifted or damaged electrodes on the octaray, perseid, 48p, 2-2-2-2-2, d-curve.It appeared that there was damage to two splines with something hanging off of the side of one of the splines visible in the photos provided.Physician noted that insertion of the device was difficult.Detachment was partial.Physician removed the pictured strand after removal.Physician aspirated the sheath while removing the catheter while monitoring ultrasound images and fluoroscopy.Strand removed intact.Strand was recovered and put into a sterile cup for return and evaluation no patient consequences.The issue with the octaray, perseid, 48p, 2-2-2-2-2, d-curve was assessed as mdr reportable for an ¿electrode damaged with foreign material¿.The issue with the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was assessed as mdr reportable for a ¿leak on the stop cock¿.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with an octaray, perseid, 48p, 2-2-2-2-2, d-curve and an electrode damaged with foreign material issue occurred.The investigation was completed on 01-feb-2023.A picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, a spline of the octaray catheter was observed bent with a lifted electrode.At this time, it is not possible to determine if the electrode has a sharp edge.No exposed wires were observed.The customer complaint was confirmed based on the picture received.The product analysis was performed as appropriate in order to find the root cause of the complaint.The device was returned to biosense webster (bwi) for evaluation.A visual inspection of the returned device was performed following bwi procedures.Visual inspection revealed that foreign material was in one of the electrodes.Also, the electrode was lifted with no wires exposed.No polyurethane (pu) was observed at the margins of the ring.A fourier transform infrared spectroscopy test (ftir) was performed; the results of ft-ir revealed that foreign white material received with the catheter showed the absorption bands for polytetrafluoroethylene (ptfe) - based material.However, the source of origin remains unknown.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The catheter is recommended for use with an 8.5 f guiding sheath because the distal splines may be damaged if used with a sheath that is not compatible.Do not use the catheter in conjunction with a transseptal sheath featuring side holes larger than 1.25 mm in diameter.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: -investigation findings: appropriate term/code not available (c22)/ investigation conclusions: cause not established (d15) were selected as related to the picture provided.-investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the customer¿s reported ¿electrode damaged with foreign material¿ issue.-investigation findings: inappropriate material (c0602) / investigation conclusions: cause not established (d15) / component code: appropriate term/code not available (g07002) were selected as related to the customer¿s reported ¿foreign particles in electrodes¿ issue.-investigation findings: stress problem identified (c0706) / investigation conclusions: cause not established (d15) / component code: electrode (g0201501) were selected as related to the customer¿s reported ¿electrode damaged¿ issue.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, PERSEID, 48P, 2-2-2-2-2, 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 ; MX
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15985072
• MDR Text Key: 308209037
• Report Number: 2029046-2022-03133
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835021141
• UDI-Public: 10846835021141
• 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: 03/01/2023

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 Expiration Date: 02/21/2023
• Device Model Number: D160901
• Device Catalogue Number: D160901
• Device Lot Number: 30750540L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 02/01/2023
• Supplement Dates FDA Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2022
• 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: 8.5F SHEATH WITH CURVE VIZ MDC; UNKNOWN BRAND CATHETER