MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D132701, PMA # P030031/S053

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

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

Patient Problem Cardiac Tamponade (2226)

Event Date 11/11/2019

Event Type  Injury  

Manufacturer Narrative

It was reported that the product is not available as the customer is retaining the product.Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.A manufacturing record evaluation (mre) review cannot be conducted because no lot number was provided by the customer.Product complaint # (b)(4).

Event Description

This event is associated with a clinical trial, sponsored by biosense webster, inc.It was reported that a (b)(6) male patient (85.7 kg, 71 in) underwent cardiac ablation with thermocool® smart touch¿ bi-directional navigation catheter on (b)(6) 2019 and developed a pericardial effusion.On (b)(6) 2019, procedure day, the patient suffered a pericardial effusion which required a pericardiocentesis.The medical intervention provided was 100 mg of protamine and a closed suction midline chest drain (gravity drainage), 2 units of packed red blood cells (prbc), and a transthoracic echocardiogram (tte).The patient¿s outcome was recovered/resolved and was discharged the next day, (b)(6) 2019.Extended hospitalization was required.The principal investigator assessed this event as moderate in severity, serious, unlikely related to study device (visitag surpoint epu), probably related to study catheters, causally related to study procedure.In the opinion of the principal investigator this event was expected.

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: SIMILAR DEVICE D132701, PMA # P030031/S053
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; 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 drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9377767
• MDR Text Key: 168244121
• Report Number: 2029046-2019-03937
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/11/2019

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 Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 85