MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE D133601, PMA # P030031/S053

Catalog Number D133604IL

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2020

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported a patient underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter wherein the deflection mechanism became stuck.During the procedure, the thermocool® smart touch¿ electrophysiology catheter¿s deflection mechanism got stuck and was difficult to be removed from the patient¿s body.No additional intervention was required to remove it.No physical damage such as wires exposed was observed.A second catheter was used to complete the operation.There was no adverse event to the patient.

Manufacturer Narrative

On (b)(6) 2020, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.# (b)(4).

Manufacturer Narrative

During the procedure, the thermocool® smart touch¿ electrophysiology catheter¿s deflection mechanism got stuck and was difficult to be removed from the patient¿s body.No additional intervention was required to remove it.No physical damage such as wires exposed was observed.A second catheter was used to complete the operation.There was no adverse event to the patient.Device evaluation details: the device evaluation has been completed.The device was visually inspected and kinks observed at the tip and on the shaft.A deflection test was performed and it was found within specifications, the catheter curve appears disturbed due to the kinks.A manufacturing record evaluation was performed, and no internal action related to the reported complaint condition were identified.The customer complaint cannot be confirmed.The catheter can deflected and relax without problems, and no deflection issues was observed; no problems found/detected.The root cause of kinks could be related with the difficult to remove the catheter during procedure.This has been determined to be a mechanical problem traced to the user.Unit was inspected prior leaving the facility as there are functional tests and inspections at control points based on the process, therefore, no capa activity is required now.Similar complaints are monitored monthly.The customer also provided a video showing the catheter¿s tip was bent, however, the video does not provide sufficient information related to the reported event and therefore no result could be obtained from it.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE D133601, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 10865888
• MDR Text Key: 247667263
• Report Number: 2029046-2020-01783
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• 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: 10/22/2020

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: 03/09/2021
• Device Catalogue Number: D133604IL
• Device Lot Number: 30363891M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 12/09/2020; 01/18/2021
• Supplement Dates FDA Received: 01/04/2021; 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1