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

Model Number D134701

Device Problems Entrapment of Device (1212); Failure to Unfold or Unwrap (1669)

Patient Problem No Code Available (3191)

Event Date 12/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).Patient code of ¿no code available¿ represents ¿surgical intervention." the photograph investigation was completed on january 10, 2020.According to the pictures provided by the customer, the catheter shaft was observed bent in a loop.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint was confirmed from the photo analysis.However, the device has not been returned for evaluation.Since no device has been received, no product investigation can be performed.If the device is received in the future, the product analysis will be performed as appropriate in order to find the root cause of the complaint.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a paroxysmal supraventricular tachycardia ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and a medical device entrapment with excessive manipulation issue occurred which resulted in a knotted loop which required surgical intervention ¿snare introduction¿.During the procedure, transseptal approach was attempted.When deflecting the thermocool® smart touch® sf uni-directional navigation catheter tip at the aortic arch to pass through the cups, it was noticed on the fluoroscopic screen that a loop was formed in the middle of the shaft due to the excessive torque applied to the catheter.The catheter could not be removed.A snare was introduced from the carotid artery to remove the catheter from the patient¿s body.While releasing the loop, the shaft kinked.Therefore, the thermocool® smart touch® sf uni-directional navigation catheter was replaced and the procedure was completed.There is no further information about the hospitalization.The physician did not provide a causality opinion for the cause of this adverse event.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The ¿kinked shaft¿ was assessed as not mdr reportable.If there is a slight bent of the shaft; however, the integrity of the catheter was not compromised, then the potential that it could cause or contribute to a death or serious injury was remote.The ¿medical device entrapment with excessive manipulation¿ and the ¿knotted catheter¿ issues were assessed as mdr reportable.¿surgical intervention¿ was coded to represent the snare introduction required to release the catheter from the patient¿s body.Since this event required surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, it was to be considered serious and mdr reportable.

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation and it was returned in the condition reported of the ¿shaft kinked¿ as it was noted on january 17, 2020 on the first visual inspection that the catheter shaft was bent approximately 15.5 cm to 19.3 cm from the distal end of the tip dome.No exposed wires were observed.Therefore, this issue of the shaft kinked/bent remains assessed as not reportable.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 number: (b)(4).

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent a paroxysmal supraventricular tachycardia ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter.During the procedure, transseptal approach was attempted.When deflecting the thermocool® smart touch® sf uni-directional navigation catheter tip at the aortic arch to pass through the cups, it was noticed on the fluoroscopic screen that a loop was formed in the middle of the shaft due to the excessive torque applied to the catheter.The catheter could not be removed.A snare was introduced from the carotid artery to remove the catheter from the patient¿s body.While releasing the loop, the shaft kinked.Therefore, the thermocool® smart touch® sf uni-directional navigation catheter was replaced and the procedure was completed.There is no further information about the hospitalization.According to the pictures provided by the customer, the catheter shaft was observed bent in a loop.The customer complaint was confirmed from the photo analysis.The product analysis was performed as appropriate in order to find the root cause of the complaint.The device was inspected, the shaft was found bent.The magnetic, temperature and force features were tested and no issues were observed.In addition, the catheter was deflecting and irrigating correctly.The catheter passed the outer diameter measure.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint regarding shaft bent and loop formed have been confirmed.The root cause of the adverse event remains unknown.The root cause of the shaft bent and loop formed were related to the procedure since it was reported that a loop was formed due to the effect of excessive torque applied to the catheter.The instructions for use ¿ifu¿ states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.Manufacturer¿s reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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: 9581851
• MDR Text Key: 189456060
• Report Number: 2029046-2020-00074
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2020
• Device Model Number: D134701
• Device Catalogue Number: D134701
• Device Lot Number: 30233057L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Date Manufacturer Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND CATHETER; UNKNOWN BRAND SNARE DEVICE
• Patient Outcome(s): Required Intervention