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 Break (1069); Entrapment of Device (1212); Material Separation (1562)

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

Event Date 12/28/2020

Event Type  malfunction  

Manufacturer Narrative

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 30454444l 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).

Event Description

It was reported that during an atrial fibrillation (afib) ablation procedure, the carto 3 system displayed a high contact force when the thermocool® smart touch® sf bi-directional navigation catheter was plugged into the front of the patient interface unit.They re-zeroed multiple times and the issue persisted.There was an error message that was displayed saying the accuracy of the force is not correct.The cable was exchanged, and the issue persisted.The catheter was exchanged, and the issue was resolved.The carto 3 system is working per specs.It was also reported that the pentaray nav high-density mapping eco catheter got stuck in the patient's mechanical mitral valve.The doctor was aware of the contraindications of the catheter.The catheter was freed by putting the sheath over the catheter and the catheter was removed.The patient's valve is fine.All splines were still attached.The catheter was removed and inspected, upon inspection of the catheter, one of the splines was noted to be stretched out.While inspecting the catheter the stretched spline fell off into the hands of the physician.The catheter was exchanged, and the issue was resolved.The case continued without any further incident.No patient consequences were reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The high force on the thermocool smart touch is not mdr-reportable.The device entrapment (pentaray) did not require additional tools or surgical intervention to resolve, therefore, it is not mdr-reportable.However, the damaged spline (pentaray) is mdr-reportable.

Manufacturer Narrative

Note: the preferred h6 component code is "g04 - mechnical"; however, that code is not supported/will not pass fda submission.On 3/1/2021, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that during an atrial fibrillation (afib) ablation procedure, the carto 3 system displayed a high contact force when the thermocool® smart touch® sf bi-directional navigation catheter was plugged into the front of the patient interface unit.They re-zeroed multiple times and the issue persisted.There was an error message that was displayed saying the accuracy of the force is not correct.The cable was exchanged, and the issue persisted.The catheter was exchanged, and the issue was resolved.The carto 3 system is working per specs.It was also reported that the pentaray nav high-density mapping eco catheter got stuck in the patient's mechanical mitral valve.The doctor was aware of the contraindications of the catheter.The catheter was freed by putting the sheath over the catheter and the catheter was removed.The patient's valve is fine.All splines were still attached.The catheter was removed and inspected, upon inspection of the catheter, one of the splines was noted to be stretched out.While inspecting the catheter the stretched spline fell off into the hands of the physician.The catheter was exchanged, and the issue was resolved.The case continued without any further incident.No patient consequences were reported.Device evaluation details: the product was returned to biosense webster for evaluation.Bwi then conducted visual inspection and microscopic examination of the returned device.Visual analysis of the returned sample revealed that one of the splines was damaged and the electrodes were missing.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.It should be noted that product failure is multifactorial.Based on the information currently available it is known that the failure is related to a contraindication of the instructions for use (ifu), which states the following: do not use this product if the patient has a mechanical valve.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; 33 technology drive; irvine CA 92618
• MDR Report Key: 11199643
• MDR Text Key: 256084661
• Report Number: 2029046-2021-00080
• 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
• Report Date: 12/28/2020

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 Expiration Date: 09/28/2023
• Device Model Number: D128208
• Device Catalogue Number: D128208
• Device Lot Number: 30454444L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Initial Date Manufacturer Received: 12/28/2020
• Initial Date FDA Received: 01/20/2021
• Supplement Dates Manufacturer Received: 03/01/2021; 03/19/2021
• Supplement Dates FDA Received: 03/19/2021; 03/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; THERMOCOOL SMARTTOUCH; UNSPECIFIED CATHETER CABLE; UNSPECIFIED SHEATH