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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Vasoconstriction (2126); Ischemic Heart Disease (2493)

Event Date 01/21/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).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 male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered st elevation and arterial spasm requiring intervention.After pulmonary vein isolation (pvi) was conducted, st suddenly increased in the inferior leads, and blood pressure decreased to the 60s.It occurred about 2 hours after the procedure was started.It was a transient increase and decreased immediately.A coronary angiogram (cag) was performed immediately after st returned to normal.In rca, flow was delayed as imaging findings, and spasm occurred.The spasm was improved by coronary injection of nitro.Lca also showed similar findings and nitro was administered to improve spasm.Cti was then performed, and the procedure was successfully completed.There was no problem with the ecg or blood pressure when the patient left the room.The physician commented that there was no causal relationship with the product.Prolonged hospitalization period (including planned) was not reported.There is not significant information regarding patient history and laboratory values.The transseptal needle used was a sl0, rf needle.The biosense webster inc (bwi) product was used in accordance with the instruction for use.Additional information was received.The physician¿s opinion on the cause of this adverse event was that it was not related to the bwi product.The patient has fully recovered.Extended hospitalization was not required.There was no significant relevant tests/laboratory data or significant medical history.The generator used in the case was a smartablate (serial number unknown).

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation.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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The device evaluation was completed on 18-apr-2022.It was reported that a male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered st elevation and arterial spasm requiring intervention.After pulmonary vein isolation (pvi) was conducted, st suddenly increased in the inferior leads, and blood pressure decreased to the 60s.It occurred about 2hours after the procedure was started.It was a transient increase and decreased immediately.A coronary angiogram (cag) was performed immediately after st returned to normal.In rca, flow was delayed as imaging findings, and spasm occurred.The spasm was improved by coronary injection of nitro.Lca also showed similar findings and nitro was administered to improve spasm.Cti was then performed, and the procedure was successfully completed.There was no problem with the ecg or blood pressure when the patient left the room.The physician commented that there was no causal relationship with the product.Device evaluation details: the device was returned to biosense webster for evaluation.Bwi conducted a visual inspection and an evaluation of all its features.Visual analysis of the returned device revealed that the shaft was bent.Per the event, several tests were performed.The magnetic, temperature and force features were tested, and no issues were observed.In addition, the product was deflecting correctly.During the irrigation test, it was observed the catheter was not irrigating correctly.The catheter was dissected, in accordance with bwi procedures.A bent was found on the irrigation tube near the tip client.The damage observed could be related to the device handling; however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device 30661671l number, and no internal action was found during the review.All devices are manufactured, inspected, and released to approved specifications as part of bwi's quality process.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the adverse event.Investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: rod/shaft (g04112) were selected as related to the bent shaft.Investigation findings: operational problem identified (c13)/ investigation conclusions: cause not established (d15) / component code: hose (g04069) were selected as related to the irrigation tubing damage.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; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13552429
• MDR Text Key: 285846895
• Report Number: 2029046-2022-00330
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2022

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: 10/29/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30661671L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2022
• Initial Date FDA Received: 02/17/2022
• Supplement Dates Manufacturer Received: 02/19/2022; 04/18/2022
• Supplement Dates FDA Received: 03/19/2022; 05/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 7FR,DEF,12MM DIA., CCW,LASSO; PENTARAY NAV ECO 7FR, D, 2-6-2; UNK SL0 RF NEEDLE; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Required Intervention
• Patient Sex: Male