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); Entrapment of Device (1212); Patient Device Interaction Problem (4001)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/22/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter and medical device entanglement occurred leading to a spline breaking off of the pentaray nav high-density mapping eco catheter.Surgical intervention was required to remove the spline.During a procedure while in the left atrium, the pentaray nav high-density mapping eco catheter was tangled with another catheter and one of the splines broke off.The physician used a snare tool and was able to retrieve the spline with no injury to the patient.The procedure continued and they did cavotricuspid isthmus (cti) ablation in the right atrium and completed the case.No further medical intervention was required as of the time of the call.The patient was stable throughout.It is unknown if the damage resulted in wires and/or braid being exposed or lifted or sharp rings.An agilis sheath was used during the procedure.

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).

Manufacturer Narrative

On 18-mar-2022, the bwi product analysis lab received the complaint device for evaluation.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 that a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter and medical device entanglement occurred leading to a spline breaking off of the pentaray nav high-density mapping eco catheter.Surgical intervention was required to remove the spline.During a procedure while in the left atrium, the pentaray nav high-density mapping eco catheter was tangled with another catheter and one of the splines broke off.The physician used a snare tool and was able to retrieve the spline with no injury to the patient.The procedure continued and they did cavotricuspid isthmus (cti) ablation in the right atrium and completed the case.No further medical intervention was required as of the time of the call.The patient was stable throughout.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Bwi conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the distal side of the spine was found detached, the detached area presented elongation.All electrodes were missing, and internal components are exposed in the tip area on the pentaray nav eco catheter.Additionally, the customer provided a picture of the complaint device to aid in the investigation.According to the picture provided, one of the splines is detached from the tip.All units are inspected prior to leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.During the investigation, no issues were observed on the catheter that could cause the entanglement with another catheter it could be related to the procedure however, this cannot be conclusively determined., other issues or circumstances may have occurred during the usage of the device that compromised its performance.The customer complaint was confirmed based on the picture received.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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13797074
• MDR Text Key: 287345914
• Report Number: 2029046-2022-00559
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30716889L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/22/2022
• Initial Date FDA Received: 03/17/2022
• Supplement Dates Manufacturer Received: 03/18/2022; 04/12/2022
• Supplement Dates FDA Received: 04/04/2022; 05/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2022
• 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: AGILIS SHEATH; UNK_SMART TOUCH BIDIRECTIONAL SF; UNSPECIFIED CS CATHETER
• Patient Outcome(s): Required Intervention