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

Model Number D134805

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Paralysis (1997)

Event Date 09/15/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.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 underwent an atrial fibrillation (afib) cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.After 3 hours since the procedure was started, while superior vena cava (svc) ablation at low output, although they checked for capture of the diaphragm, the diaphragm became sluggish.No further ablation was performed.It seemed the issue resolved towards the end of the case.The physician commented there is no causal relationship between the product and the adverse event occurrence.There¿s no indication that medical/surgical intervention was provided.It is unknown if extended hospitalization was required.No bwi product malfunctions were reported.Despite there¿s no indication of intervention or prolonged hospitalization, this event is being conservatively reported for the diaphragmatic paralysis.The available information suggests that pacing was being applied to the phrenic nerve to if see the diaphragm was responding or "twitching", but after the ablation it was identified that response was lost.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The physician¿s causality opinion is procedure.No medical intervention was required.The patient¿s condition has improved.Since this diaphragmatic paralysis might result in permanent impairment to a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

Per internal review, it was identified that the lot number, manufacture date, and expiration date of the complaint device was available.Lot number: 30396480m; expiration date: 6/28/2021; manufacture date: 6/29/2020.Sections d4 and h4 have been updated accordingly.A manufacturing record evaluation was performed for the finished device 30396480m number, and no internal action related to the complaint was found during the review.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: 10719068
• MDR Text Key: 212538046
• Report Number: 2029046-2020-01491
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/18/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30396480M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 01/07/2021
• Supplement Dates FDA Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other