MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH SMALL; INTRODUCER, CATHETER

Model Number D138501

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 10/06/2021

Event Type  Injury  

Manufacturer Narrative

Device investigation details: the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A device history record was performed for the finished device 00001658 number, and no internal actions related to the complaint were found during the review.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda."biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2021-01860 (b)(4) (thermocool® smart touch® sf bi-directional navigation catheter).(2) mfr # (b)(4) (carto vizigo¿ 8.5f bi-directional guiding sheath small).

Event Description

It was reported that a male patient underwent a cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath small and a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered cardiac tamponade requiring pericardiocentesis.After the septal puncture, cardiac tamponade occurred because it was considered that the septal side was accidentally attached when carto vizigo¿ 8.5f bi-directional guiding sheath small and a thermocool® smart touch® sf bi-directional navigation catheter were inserted from right atrium (ra) into the left atrium (la).Blood pressure did not decrease very much, but pericardial effusion was confirmed by echocardiography, and drainage was performed.After one hour, the bleeding stopped, and the patient returned to the ward.The patient was discontinued.Drainage and transfusion were performed, and hemostasis was achieved, and the procedure was completed.The causality with the product is unknown.The physician commented that it was thought to have occurred at the transition from right defecation to left atrium, but there was no comment about the effect of the product.The physician¿s opinion on the cause of this adverse event is that it was procedure related.It was thought to have occurred at the transition from the right atrium to the left atrium, but it¿s causal relationship to bwi products was unknown.The event occurred during the transseptal phase.Drainage and transfusion were performed as intervention.Patient¿s outcome from the adverse event was reported as improved.It was not reported extended hospitalization was required.A smartablate generator was used during the procedure.A transseptal puncture was performed but product information was unknown.Prior to noting the cardiac tamponade (ct) ablation was not performed.There was no evidence of steam pop.It was not reported that inappropriate use was conducted without ifu.Additional information received indicated drainage and blood transfusion were performed, hemostasis was achieved, and the treatment was completed.The patient is now recovering.

• Brand Name: CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH SMALL
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12732530
• MDR Text Key: 284299918
• Report Number: 2029046-2021-01861
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• Combination Product (y/n): N
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2022
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001658
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: JPN CARTO 3 SYSTEM; PENTARAY NAV ECO 7FR, D, 2-6-2.; SOUNDSTAR ECO GE 8F CATHETER.; THMCL SMTCH SF BID, TC, D-F.
• Patient Outcome(s): Life Threatening; Required Intervention