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

Catalog Number D128211

Device Problems Signal Artifact/Noise (1036); Material Twisted/Bent (2981)

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

Event Date 02/03/2024

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on (b)(6) 2024.The device evaluation was completed on (b)(6) 2024.The product was returned to biosense webster (bwi) for evaluation.A visual inspection and electrical evaluation of the returned device were performed following bwi procedures.Visual analysis revealed that spline a was broken.This issue may be related to the electrical issue reported.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 instructions for use contain the following warning stated in the carto 3 system manual: excessive bending or kinking of the catheter shaft or spines may damage lead wires and cause loss of electrode function.Do not use excessive force to advance or withdraw the catheter through the guiding sheath if resistance is encountered.Prior to removing or repositioning the catheter, use direct imaging guidance such as fluoroscopy or ultrasound to confirm that the spline assembly is not entangled with another catheter or with an anatomical structure.Exercise caution when maneuvering the catheter near the valvular apparatus to avoid entanglement or entrapment which may result in the need for surgical intervention.The root cause of this condition may be related to the handling of the device outside the manufacturing facilities; however, this could not be conclusively determined.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.Manufacturer¿s reference number: (b)(4).

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with a pentaray nav high-density mapping eco catheter for which biosense webster¿s product analysis lab (pal) identified that spline a was broken.Initially reported an ecg signal interference.During the procedure, the signal interference (noise) was observed on the intracardiac (ic), body surface (bs), or all ecg (bs + ic) channels.A second device was used to complete the procedure.There was no adverse event reported on the patient.Additional information was received.The signal interference (noise) was observed on the carto.The physician had an ecg signal available to monitor the patient¿s heart rhythm.During the signal interference, the affected catheter was inside the patient¿s body.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6) 2024, spline a was broken.This event was originally considered non-reportable, however, bwi became aware that spline a was broken on (b)(6) 2024 and have assessed this returned condition as 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) during additional review on 04-apr-2024, correction necessary to the 3500a initial as should have included that the picture provided reflected that the spline of the catheter was bent which was assessed as non mdr reportable and the analysis should have included additional description on the "broke" spline.Therefore updated the following: -b5.Event description should have been: it was reported that a patient underwent a paroxysmal atrial fibrillation procedure with a pentaray nav high-density mapping eco catheter for which biosense webster¿s product analysis lab (pal) identified that spline a was broken, the internal components were exposed.Initially reported an ecg signal interference.During the procedure, the signal interference (noise) was observed on the intracardiac (ic), body surface (bs), or all ecg (bs + ic) channels.A second device was used to complete the procedure.There was no adverse event reported on the patient.Picture provided which reflected the spline of the catheter bent.Additional information was received.The signal interference (noise) was observed on the carto.The physician had an ecg signal available to monitor the patient¿s heart rhythm.During the signal interference, the affected catheter was inside the patient¿s body.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 07-mar-2024, spline a was bent and broken, the internal components were exposed, and evidence of elongation damage was observed.This event was originally considered non-reportable, however, bwi became aware that spline a was broken, the internal components were exposed on 07-mar-2024 and have assessed this returned condition as reportable.Added under h6.Medical device problem code: ¿material twisted / bent (b)(6)." in addition, the product investigation was reopened to clarify/correct the investigation findings which resulted in the following updated investigation on 10-apr-2024.The product was returned to biosense webster (bwi) for evaluation.A visual inspection and electrical evaluation of the returned device were performed following bwi procedures.Visual analysis revealed that spline a was bent and broken, the internal components were exposed, and evidence of elongation damage was observed.A picture was sent by the customer showing that a spline was bent.An electrical test was performed, and two open circuits were found on the tip area.A manufacturing record evaluation was performed for the finished device batch number, and internal actions were identified.The electrical and bent tip issues reported by the customer were confirmed.The potential cause of the bent spline may be related to the usage of the device during the procedure; however, the elongation and broken spline damage may be related to the handling of the device after the procedure; however, this could not be conclusively determined.The instructions for use (ifu) state that: the catheter is recommended for use with an 8 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 transseptal sheaths featuring side holes larger than 1.25 mm in diameter.Do not use excessive force to advance or withdraw the catheter through the guiding sheath when resistance is encountered.Prior to removing or repositioning the catheter, use direct imaging guidance such as fluoroscopy to confirm that the spline assembly is not entangled with another catheter or with an anatomical structure.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.Coding updated and added under h6.Investigation findings "open circuit (c0205)", under h6.Component code "electrical lead/wire (g02015)" and under h6.Type of investigation "analysis of data provided by user/third party (b15)":.In addition, added explanation of codes: -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 ¿spline bent¿ issue.-investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the biosense webster inc.Analysis finding of the ¿spline a broken, the internal components were exposed¿.Investigation findings: open circuit (c0205)/ investigation conclusions: cause not established (d15) / component code: electrical lead/wire (g02015) were selected as related to the customer¿s reported ecg signal interference.

• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18992470
• MDR Text Key: 339222612
• Report Number: 2029046-2024-01048
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D128211
• Device Lot Number: 31126676L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2023
• 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: UNK_CARTO 3.