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

Model Number D128208

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 12/01/2021

Event Type  malfunction  

Event Description

It was reported that an unknown patient underwent a persistent atrial fibrillation (afib) ablation procedure with an pentaray nav high-density mapping eco catheter.There was foreign material tangled in the splines.When removing the catheter, they found a transparent filament, which seems to be in plastic tangled in the splines of the catheter.The catheter was changed due to the possible risk of release of thread into the bloodstream.The procedure continued.There were no procedural delays or patient consequences were reported.Foreign material on usable length of catheter is mdr-reportable.

Manufacturer Narrative

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

Manufacturer Narrative

On 27-dec-2021, bwi received additional information regarding the event.The issue was not noticed before use.Long translucent flat filament seemed like plastic.The device was used on the patient.No resistance while introducing or retracting the catheter.The insertion tool was used during the procedure.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 2-feb-2022, the product investigation was completed as the complaint device was not returned.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30646423l number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On (b)(6) 2022, the bwi product analysis lab received the device for evaluation.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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 18-jan-2023, the product investigation was completed.It was reported that an unknown patient underwent a persistent atrial fibrillation (afib) ablation procedure with an pentaray nav high-density mapping eco catheter.There was foreign material tangled in the splines.When removing the catheter, they found a transparent filament, which seems to be in plastic tangled in the splines of the catheter.The catheter was changed due to the possible risk of release of thread into the bloodstream.The procedure continued.There were no procedural delays or patient consequences were reported.Device evaluation details: visual analysis revealed that a pentaray spline was bent, and within this spline, an electrode was squashed as well.Additionally, a string plastic-like material was found.The sample was sent to a fourier transform infra-red analysis (ftir) to determine its chemical composition.Infrared results revealed that foreign material showed the absorption bands for polytetrafluoroethylene (ptfe) based material.Based on the results obtained, the material could be an inner liner from a carto vizigo sheath, since the inner liner of the sheath is made from this material.A spline of the pentaray was bent, and within this spline, an electrode was bent as well.The electrode damage could tear the sheath and cause the sheath liner detachment; however, this it could not conclusively determined.A manufacturing record evaluation was performed for the finished device 30646423l number, and no internal action related to the complaint was found during the review.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instructions for use contain (ifu) the following recommendations: do not introduce the catheter into a guiding sheath with the catheter¿s distal spines folded backward toward the handle.Collapse the spines together using the insertion tube prior to insertion.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: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13046376
• MDR Text Key: 288632645
• Report Number: 2029046-2021-02224
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012224
• UDI-Public: 10846835012224
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/20/2023

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: D128208
• Device Catalogue Number: D128208
• Device Lot Number: 30646423L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 12/27/2021; 02/02/2022; 07/19/2022; 01/18/2023
• Supplement Dates FDA Received: 01/18/2022; 02/09/2022; 08/08/2022; 01/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2021
• 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