MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D128208

Device Problems Contamination /Decontamination Problem (2895); Device-Device Incompatibility (2919); Sharp Edges (4013)

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

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter and a foreign material on the catheter.It was reported that during the procedure, when the pentaray nav high-density mapping eco catheter was taken out of the 8.5 fr stryker reprocessed agilis sheath (non-bwi product), the physician noted it was difficulty on removing it.Physician noted there was some thin material that appears to be plastic inside the sheath.No occlusion when irrigating the sheath was noticed.The sheath did not appear to be narrowed.The agilis sheath was replaced with another agilis sheath and the pentaray nav high-density mapping eco catheter was also replaced with another pentaray nav high-density mapping eco catheter, and the issue resolved.There was no patient consequence reported.The reported resistance with the agilis sheath i not considered not mdr reportable since interference or friction between devices is a known occurrence and the potential for patient injury is remote.

Manufacturer Narrative

On (b)(6) 2020, the bwi product analysis lab received the complaint device for evaluation.Initial visual analysis observed there was no foreign material.On (b)(6) 2021, during additional inspection, the electrodes were found squashed and lifted.Debris were observed tangled in the damaged electrodes.The issue of the electrodes being damaged (squashed and lifted) has been assessed as an mdr reportable finding.The issue of debris (foreign material) continues to be deemed mdr reportable.The product 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.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

It was reported a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter and a foreign material on the catheter.It was reported that during the procedure, when the pentaray nav high-density mapping eco catheter was taken out of the 8.5 fr stryker reprocessed agilis sheath (non-bwi product), the physician noted it was difficulty on removing it.Physician noted there was some thin material that appears to be plastic inside the sheath.No occlusion when irrigating the sheath was noticed.The sheath did not appear to be narrowed.Device evaluation details: the device evaluation has been completed.The returned device was inspected, and some electrodes were found squashed and lifted with foreign material underneath.Then, outer diameter (od) test was measured, and polyurethane (pu) application was found correctly applied however, some od¿s were out of specification due the damage observed.Ft-ir analysis (fourier transformed- infrared) was performed on foreign material and it showed the absorption bands for polytetrafluoroethylene (ptfe)-based material.This material is widely used in medical devices as temperature insulating, protective coating, etc.A manufacturing record evaluation was performed, and no internal action related to the complaint was found during the review.Customer complaint was confirmed.The damage and foreign material found on the device could be related to the usage of the device during the procedure.The instructions for use (ifu) states that excessive force should not be used to advance or withdraw the catheter through the guiding sheath when resistance is encountered.Also, device is designed for deployment in a heart chamber through an 8f guiding sheath as the distal spines may be damaged if used with a sheath that is not compatible.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on 3/15/2021, it was noticed incorrect information was submitted in section h10.Of the 3500a supplemental (follow-up) medwatch report # 2.The incorrect information is the manufacturer's ref.#.The incorrect reference is (b)(4) the correct reference # is (b)(4).

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 10974148
• MDR Text Key: 247900243
• Report Number: 2029046-2020-01903
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012224
• UDI-Public: 10846835012224
• Combination Product (y/n): N
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/06/2023
• Device Model Number: D128208
• Device Catalogue Number: D128208
• Device Lot Number: 30439466L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8.5 FR STRYKER REPROCESSED AGILIS SHEATH; 8.5 FR STRYKER REPROCESSED AGILIS SHEATH; PENTARAY NAV ECO 7FR, F, 2-6-2