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

Model Number D134801

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stenosis (2263); No Code Available (3191)

Event Date 10/15/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed 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 female patient ((b)(6)) underwent cardiac ablation procedure for premature ventricular contraction (pvc) with thermocool® smart touch® sf bi-directional navigation catheter and suffered coronary artery stenosis requiring surgical intervention.After 1st ablation catheter (30413073m) was connected and immediately after inserting into the patient¿s body, temperature and the impedance were not displayed.The issue was resolved by changing the catheter.With the 2nd catheter, the area near the apex of the left crown [ventricle] was ablated.After that, st elevation was observed and coronary angiography (cag) was performed.A stenosis was found at the left circumflex artery (lcx) entrance.Percutaneous coronary intervention (pci) was performed.After pci, the blood flow of lcx was confirmed, and after confirming that vital signs were stable, the patient was discharged.Four days after the case, cag was performed again, and a recovery tendency was observed at the stenotic site, and the condition such as vital signs was stable.There was no report of extended hospitalization.The patient ¿s condition was improved.The physician¿s commented that the causal relationship with this product is low.The st-segment elevation was most probably a symptom of the coronary artery stenosis and thus is not coded.Since coronary artery stenosis required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure it is mdr reportable under the 2nd catheter (thermocool® smart touch® sf bi-directional navigation catheter).The no temperature and impedance issues were assessed as not reportable.The potential for patient injury was low.

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30416416m 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: 10827390
• MDR Text Key: 216333824
• Report Number: 2029046-2020-01692
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2021
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30416416M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THMCL SMTCH SF BID, TC, D-D; UNKNOWN BRAND CABLE; UNKNOWN BRAND CABLE
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 66