MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D133602

Device Problems Entrapment of Device (1212); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30348980m 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a procedure with a thermocool® smart touch¿ electrophysiology catheter and issues of deflection stuck and medical device entrapment with excessive manipulation required occurred.It was reported that the curve of the thermocool® smart touch¿ electrophysiology catheter got stuck in a deflected position and as consequence, it was hard to pull the catheter out of the patient¿s body.The catheter handle was working properly but the catheter was not responding, it was not possible to remove the curve.No physical damage to the catheter was observed.It is unknown how the catheter was removed from the patient¿s body; however, it was confirmed the procedure was successfully completed and no patient consequences occurred.There¿s no information if surgical intervention or additional equipment/tool was required to remove the catheter from the patient¿s body; however, since it was confirmed that it was not possible to remove the catheter curve, it is most likely that an additional tool would have to be inserted to help the catheter to release its curve in order to remove it safely.Therefore, additional clarification was requested.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.With the information available, this event was assessed as mdr reportable for issues of ¿deflection stuck¿ and ¿medical device entrapment with excessive manipulation required¿.

Manufacturer Narrative

Additional information was received on (b)(6) 2020, that the catheter was removed from the patient¿s body without requiring any intervention.Per this additional information, removed the reportable assessment of the h6.Medical device problem code of ¿entrapment of device or device component¿ submitted under the 3500a initial as it was confirmed the catheter did not got entrapped nor required additional tools/interventions to be removed.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 ELECTROPHYSIOLOGY CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 10793174
• MDR Text Key: 229280255
• Report Number: 2029046-2020-01638
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: 10846835009002
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• 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: 10/08/2020

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: 02/11/2021
• Device Model Number: D133602
• Device Catalogue Number: D133602
• Device Lot Number: 30348980M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 11/13/2020
• Supplement Dates FDA Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1