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 Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

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.Additionally, if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) (left side) ablation procedure with a pentaray nav high-density mapping eco catheter and a clotting issue occurred.During the procedure the pentaray nav high-density mapping eco catheter had a kink at the distal shaft and it got caught in a valve leaflet.The pentaray nav high-density mapping eco catheter was pulled back and was freed from the valve and then removed from the patient.It was then noted that the irrigation had stopped and there was a clot in the catheter¿s irrigation port.The procedure was then aborted.The patient was still in the procedure room under general anesthesia at the time of the call.On 12/12/2019, additional information about the event and device was received.It was reported that the damage on the pentaray nav high-density mapping eco catheter did not result in wires being exposed nor any lifted or sharp rings.The kink was observed midshaft.The sheath that was used was a short 8f st.Jude.The pentaray nav high-density mapping eco catheter was removed from the patient with difficulty and resistance.There were no error messages displayed by the system related to temperature or flow on the catheter.The patient was anticoagulated, but the activated clotting time (act) is unknown.The caller is not aware of any patient consequence.A smartablate generator and a smartablate pump were used in the procedure.Additionally, the biosense webster inc.(bwi) product analysis lab (pal) received the device for evaluation on 12/11/2019.Initial visual inspection found the shaft is kinked approximately 82 cm ¿ 84 cm from the distal tip.There also appeared to be something blocking the irrigation port.The customer¿s reports of clotting and the product returned condition of finding something blocking the irrigations port, the issue of clotting has been assessed as an mdr reportable malfunction.The issues of kink in the shaft, occlusion of irrigation port, device entrapment and procedure cancellation were not life threatening and did not result in permanent impairment of a body function or permanent damage to a body structure; or did not necessitate medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, therefore the potential risk that these could cause or contribute to a serious injury or death to the operator or patient is remote.As such, these issues are considered not mdr reportable.

Manufacturer Narrative

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) (left side) ablation procedure with a pentaray nav high-density mapping eco catheter and a clotting issue occurred.During the procedure the pentaray nav high-density mapping eco catheter had a kink at the distal shaft and it got caught in a valve leaflet.The pentaray nav high-density mapping eco catheter was pulled back and was freed from the valve and then removed from the patient.It was then noted that the irrigation had stopped and there was a clot in the catheter¿s irrigation port.The procedure was then aborted.The patient was still in the procedure room under general anesthesia at the time of the call.Additionally, the biosense webster inc.(bwi) product analysis lab (pal) received the device for evaluation on 12/11/2019.Initial visual inspection found the shaft is kinked approximately 82 cm ¿ 84 cm from the distal tip.There also appeared to be something blocking the irrigation port.The customer¿s reports of clotting and the product returned condition of finding something blocking the irrigations port, the issue of clotting has been assessed as an mdr reportable malfunction.Device evaluation details: the device evaluation has been completed.The device was initially inspected and shaft was kinked approximately 82 cm ¿ 84 cm from the distal tip.There appears to be something blocking the irrigation port.Then, during the second visual was confirmed shaft was kinked approximately 82 cm ¿ 84 cm from the distal tip, no metal exposed was observed.No more anomalies were observed.Irrigation test was performed and it was found within specifications, the catheter was irrigating correctly, no irrigation issues were observed.The catheter pass deflection test and the catheter outer diameter was measured and it was found within specification.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint regarding shaft bent has been confirmed.The root cause of the shaft bent cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the handling of the device during the procedure, however, this cannot be conclusively determined.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.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.; 33 technology drive; irvine CA 92618
• MDR Report Key: 9533678
• MDR Text Key: 200059975
• Report Number: 2029046-2019-04079
• 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
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2022
• Device Model Number: D128208
• Device Catalogue Number: D128208
• Device Lot Number: 30261120L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Date Manufacturer Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US; ST JUDE 8F SHORT SHEATH