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

Catalog Number D134805

Device Problems Crack (1135); Entrapment of Device (1212)

Patient Problem No Code Available (3191)

Event Date 04/30/2019

Event Type  Injury  

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation on may 14, 2019 and it was reported that the pebax sleeve appears to be reddish/brownish in color, the distal tip and electrodes appear to be fully intact, and the shaft has been severed, exposing internal wires.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.A manufacturing record evaluation was performed for the finished device 30139700l number, and no internal actions was found during the review.Manufacturer's reference #: (b)(4).

Event Description

It was reported that a male patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a medical device entrapment occurred requiring surgical intervention.During the procedure, the distal electrode tip near the sensor broke.No braids were exposed, the glass capsule where the force sensor sits is what broke, but everything was still fully connected.No sharp electrodes were observed.When the catheter was being pulled out of the patient¿s body, it got caught in the aorta.The physician could not advance or retract it on its own.The vascular surgeon was called in and used a short 8 fr sheath to get the catheter out of the body.The catheter handle was then cut and removed so only the wire was left.The short 8 fr sheath was removed and a long 8 fr was placed over the ablation catheter wire.Once reaching the broken tip that was stuck the long sheath advancement allowed the catheter to become dislodged and was carefully pulled back into the long sheath to be removed without any consequence.The broken tip was removed from adherence to the aorta with minimally invasive approach.Extended hospitalization was not required.The patient fully recovered.No damage from broken catheter event.Physician¿s opinion regarding the cause of the event is that it was caused by the catheter manipulation and aggressive torquing of catheter to reach desired spot in the left ventricle.Patient¿s relevant history included calcification on the aorta.The issue of pebax cracked/broken and medical device entrapment - excessive manipulation were assessed as a reportable issues.The customer also confirmed that the shaft was cut to remove the handle and allow advancing a new sheath over the catheter.This manipulation leaves the catheter internal components exposed.This manipulation will be considered part of the actions required to retract the device and captured under the medical device entrapment excessive manipulation issue.Since this adverse event required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr reportable.

Manufacturer Narrative

Investigation summary: it was reported that a male patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a medical device entrapment occurred requiring surgical intervention.During the procedure, the distal electrode tip near the sensor broke.No braids were exposed, the glass capsule where the force sensor sits is what broke, but everything was still fully connected.No sharp electrodes were observed.When the catheter was being pulled out of the patient¿s body, it got caught in the aorta.The physician could not advance or retract it on its own.The vascular surgeon was called in and used a short 8 fr sheath to get the catheter out of the body.The catheter handle was then cut and removed so only the wire was left.The short 8 fr sheath was removed, and a long 8 fr was placed over the ablation catheter wire.Once reaching the broken tip that was stuck the long sheath advancement allowed the catheter to become dislodged and was carefully pulled back into the long sheath to be removed without any consequence.The broken tip was removed from adherence to the aorta with minimally invasive approach.The device was inspected, and reddish material was observed inside the pebax.The distal tip and electrodes were observed without damage and the shaft was found cut exposing internal wires.Then during the second visual inspection the pebax was observed cut with metal exposed.In addition, the customer provided three pictures of the reported issue, therefore, an investigation of the received photographs was performed, and reddish material can be observed inside the pebax confirming the customer complaint and the condition of the returned device.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.The customer complaint was confirmed.The root cause of the damage on pebax and the damage on the shaft 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 manipulation of the device during the procedure.According to the physician¿s opinion, the cause of the event is that it was caused by the catheter manipulation and aggressive torquing of catheter to reach desired spot in the left ventricle.Manufacturer's reference # (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: 8637316
• MDR Text Key: 145967584
• Report Number: 2029046-2019-03163
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 04/30/2019

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 Expiration Date: 11/25/2019
• Device Catalogue Number: D134805
• Device Lot Number: 30139700L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Initial Date Manufacturer Received: 04/30/2019
• Initial Date FDA Received: 05/23/2019
• Supplement Dates Manufacturer Received: 07/15/2019
• Supplement Dates FDA Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 84