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

Model Number D134805

Device Problem Failure to Unfold or Unwrap (1669)

Patient Problem No Code Available (3191)

Event Date 10/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.A manufacturing record evaluation was performed for the finished device 30248507m number, and no internal actions related to the complaint was found during the review.Investigation summary: an evaluation of the picture was performed.The catheter was observed to be knotted.The customer complaint regarding the knotted catheter was confirmed, however, the root cause of the adverse event remains unknown.Further investigation will be performed once the device is received.Manufacturer's reference # (b)(4).

Event Description

It was reported that a (b)(6)-year-old male patient underwent an idiopathic ventricular tachycardia ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter, which became knotted and required surgical intervention to remove it.It was reported that during the procedure, there was difficulty maneuvering the catheter.The proximal end of the catheter became knotted when going into the right ventricle (rv) from the left ventricle (lv).The catheter did not become unknotted and the physician was unable to remove the catheter.Therefore, the patient went to the operating room (or), where the cardiovascular surgeon had to surgically remove both the catheter and sheath.Extended hospitalization was required because of the adverse event.The patient has fully recovered with no residual effects.Physician¿s opinion regarding the cause of the adverse event is that it was procedure related and patient condition related.There was no physical damage such as exposure of any internal catheter component, electrode sharp edges or component detachment.The sheath used during the procedure was a st.Jude medical 8 french ref sheath.On october 17, 2019, a photograph was received with images of the knotted catheter.However, there does not appear to be any visible damage on the catheter based on the photograph.

Manufacturer Narrative

On(b)(6)2020 , additional information was received from the customer advising that the lot number initially reported was incorrect.Lot number was initially reported as 30248507m, however, the correct lot number is 30223565l.Therefore, the following sections have been updated: d4.Lot, d4.Expiration date, h4.Device manufacture date, additionally, on (b)(6)2020 , the biosense webster, inc.Product analysis lab received the device for evaluation, and it was found inserted in the sheath of 8 french and with a knot at the tip.The biosense webster, inc.Product analysis lab received the device 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference # (b)(4).

Manufacturer Narrative

Investigation summary it was reported that a 26-year-old male patient underwent an idiopathic ventricular tachycardia ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter, which became knotted and required surgical intervention to remove it.It was reported that during the procedure, there was difficulty maneuvering the catheter.The proximal end of the catheter became knotted when going into the right ventricle (rv) from the left ventricle (lv).The catheter did not become unknotted and the physician was unable to remove the catheter.Therefore, the patient went to the operating room (or), where the cardiovascular surgeon had to surgically remove both the catheter and sheath.Extended hospitalization was required because of the adverse event.The patient has fully recovered with no residual effects.Physician¿s opinion regarding the cause of the adverse event is that it was procedure related and patient condition related.The device was visually inspected, and it was found inserted in the 8 french sheath of and with a knot at the tip.The magnetic and temperature features were tested, and no issues were observed.The force check could not be performed due the catheter not irrigating.The catheter could not be deflected due to the knotted condition.Then, an irrigation test was performed, and the catheter failed.The catheter was dissected on the shaft area, the irrigation tubing was found occluded with reddish material.A manufacturing record evaluation was performed for the finished device 30248507m number, and no internal actions related to the complaint was found during the review.The customer complaint regarding a knot has been confirmed.The root cause of the adverse, irrigation tube occluded, and tip damage could be related to the procedure.The 8 french sheath used during the procedure was not recommended according the instructions for use (ifu), since any sheath less than 8.5 french is contraindicated.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.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: 9290447
• MDR Text Key: 178576525
• Report Number: 2029046-2019-03857
• 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,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2020
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30223565L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Date Manufacturer Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 26 YR
• Patient Weight: 89