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

Model Number D128211

Device Problems Break (1069); Positioning Problem (3009)

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

Event Date 01/17/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(6).Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, the tip was observed semi-deflected; however, the piston was not observed in the photo provided. also, it can be observed that the tip is separated at the transition between the shaft and the tip.A manufacturing record evaluation was performed for the finished device number 30811971l, and no internal actions related to the reported complaint were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter.Deflection issue.It was reported that during the operation, catheter was unable to deflect or relax completely.A second device was used to complete the operation.There was no adverse event reported on patient.Deflection issue is not mdr-reportable.However, bwi received pictures of the complaint device.According to pictures provided by the customer, the tip was observed semi-deflected; however, the piston was not observed in the photo provided.Also, it can be observed that the tip is separated at the transition between the shaft and the tip.Broken tip is mdr-reportable.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter.Deflection issue.It was reported that during the operation, catheter was unable to deflect or relax completely.A second device was used to complete the operation.There was no adverse event reported on patient.However, bwi received pictures of the complaint device.According to pictures provided by the customer, the tip was observed semi-deflected; however, the piston was not observed in the photo provided.Also, it can be observed that the tip is separated at the transition between the shaft and the tip.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and an evaluation of all features of the device were performed following bwi procedures.Visual inspection was performed and the tip was found separated from the shaft with the internal parts still attached, however, some polyurethane (pu) was found evidencing a proper manufacturing assembly.  a deflection test was performed, and the curve was deflecting within specifications.No deflection issues were observed.The broken tip issue reported by the customer was confirmed, however, the deflection issue could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: no device problem found (c19)/ no problem detected (d14) are associated with the physical analysis of the device as the deflection issue was not able to be replicated during testing.Investigation findings: cause not established (d15)/ mechanical problem identified (c07) are associated with the physical investigation and photo analysis, as both confirmed the customer report of a broken/separated tip.The cause of the broken/separated tip was not established and the defection issue was not confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16360761
• MDR Text Key: 309373489
• Report Number: 2029046-2023-00269
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2023

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: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30811971L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/13/2023
• Supplement Dates Manufacturer Received: 02/27/2023
• Supplement Dates FDA Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2022
• 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