MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problems Entrapment of Device (1212); Material Twisted/Bent (2981)

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

Event Date 10/27/2020

Event Type  malfunction  

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).

Event Description

It was reported that a patient with an epic mechanical mitral valve was hospitalized in cardiology for ablation of ventricular disorders.Ablation of several foci of ventricular tachycardia (vt) located at the level of large scar of the inferior and apical myocardial infarction, as well as at the level of the mitral isthmus was done with a thermocool® smart touch® sf bi-directional navigation catheter.While ablating, the catheter got stuck inside the left ventricle (lv) at the level of the mechanical mitral valve.A transesophageal ultrasound was performed to assess its position, and it seemed to be impacted in the lateral wall under the valve.After traction on the catheter, it finally come off the patient¿s body.The catheter was damaged, and the physician assessed there was a risk of valve injury to the patient.The procedure time increased due to the issue experienced.The catheter was replaced, and the procedure was continued without further issues.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.With the information available, this complaint will not be considered an actual cardiac valve injury since there¿s no confirmation that a valve injury indeed occurred or that the patient required of medical/surgical intervention or prolonged hospitalization.The medical device entrapment will be considered that it required excessive manipulation to have been removed, since it is most likely that excessive force/manipulation would have been applied to get the catheter released from the patient¿s mechanical valve.Therefore, the medical device entrapment was assessed as mdr reportable.The physical damage to the catheter was assessed as not mdr reportable since there¿s no indication of tip detachment, internal components exposed or sharp/lifted electrodes.The procedure delay reported will not be coded as there's no information that the delay was over 30 minutes or that it represented an increased risk to the patient.Should more information become available, it will be reviewed and processed accordingly.Per the instructions for use, the usage of this product is contraindicated in patients with prosthetic valves as the catheter may damage the prosthesis.

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device on 1/22/2021 for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Additional information received on 01/11/2021: surgical intervention was not required.The catheter was damaged at the distal end.It was confirmed that the catheter was not stuck in a fully deflected position.The patient fully recovered.Graph, dashboard, vecotr and visitag were used as force visualization features.The visitag stability parameters were 2mm, 4s, 70% > 8gr.Time was used as coloring option.The sheath used was a non-bwi product (agilis 8.5 fr from abbott).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that a patient with an epic mechanical mitral valve was hospitalized in cardiology for ablation of ventricular disorders.Ablation of several foci of ventricular tachycardia (vt) located at the level of large scar of the inferior and apical myocardial infarction, as well as at the level of the mitral isthmus was done with a thermocool® smart touch® sf bi-directional navigation catheter.While ablating, the catheter got stuck inside the left ventricle (lv) at the level of the mechanical mitral valve.A transesophageal ultrasound was performed to assess its position, and it seemed to be impacted in the lateral wall under the valve.After traction on the catheter, it finally come off the patient¿s body.The catheter was damaged, and the physician assessed there was a risk of valve injury to the patient.The procedure time increased due to the issue experienced.The catheter was replaced, and the procedure was continued without further issues.Additional information was received stating surgical intervention was not required.The catheter was damaged at the distal end.It was confirmed that the catheter was not stuck in a fully deflected position.The patient fully recovered.The investigational analysis has been completed on 02/09/2021.The catheter was visually inspected, a hole on the pebax was found.Then, an outer diameter test of polyurethane test was performed, and it found that the ring measurements are within specifications, no issues were observed.A manufacturing record evaluation was performed for the finished device 30430171l number, and no internal action related to the complaint was found during the review.No malfunctions were observed on the device during the product analysis that could be related to the reported event.The root cause of the hole on the pebax 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 root cause of the medical device entrapment and the physical damage to the catheter remains unknown since no problem was found/no problem was detected.The use of thermocool smarttouch¿ sf bi-directional navigation catheters in patients with prosthetic valves is contraindicated, as specified in the device instructions for use (ifu).As such, conclusion code of ¿cause not established¿, result code of ¿material and/or chemical problem identified¿, and component code of ¿membrane¿ are related to the hole on the pebax that was encountered during the evaluation of the device.Initially, the lot number was reported as unknown.However, during the investigational analysis of the returned device, the lot number was able to be retrieved.Therefore, d4.Lot, d 4.Expiration date, and h 4.Device manufacture date fields were populated on this report.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The biosense webster, inc.Product analysis lab observed a hole on the pebax on 01/27/2021.The returned condition observed of the hole on the pebax was assessed as mdr reportable.Therefore, the awareness date for this reportable lab finding is 01/27/2021.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: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11016176
• MDR Text Key: 243499488
• Report Number: 2029046-2020-01946
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/17/2020

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: 09/08/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30430171L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 01/11/2021; 01/27/2021; 02/09/2021
• Supplement Dates FDA Received: 01/22/2021; 02/25/2021; 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBOTT AGILIS 8.5FR.; CARTO 3 SYSTEM.; UNK BRAND CATHETER.