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

Model Number D138502

Device Problems Material Separation (1562); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2021

Event Type  malfunction  

Event Description

It was reported that during an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a hemostatic valve separation issue occurred.It was reported that the hemostatic valve of the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium had been damaged when thermo cool smart touch surround flow catheter which had been passed through the sheath was removed from the right atrium as blood began to leak from the hemostatic valve.The event occurred 5.5 hours after the start of the procedure.Since the catheter was not ablated after removal, it was not problematic because the catheter was not passed through the sheath.The procedure was completed without patient's consequence.In addition, it was also reported that the deflection orientation of the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was difficult to sense even though it can be seen on 3d.The sheath is long, for example, if the tissue at the puncture site is hard, the patient may feel a catch when pushing the sheath, which may cause stress.The customer¿s reported deflection issue is not mdr reportable since the most likely consequence for this issue is an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death is remote.This is event is mdr reportable for the product malfunction of hemostatic valve separation.

Manufacturer Narrative

Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Investigation is in progress, once completed a supplemental will be submitted.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(6).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

On (b)(6)2021, biosense webster inc.Received information in response to follow up attempts to clarify if there was blood return was observed or not.The information received confirmed blood return was observed.Blood began to leak from the hemostatic valve.Patient hemodynamics were not compromised due to bleeding.The exact volume of blood that was lost is unknown.No medical intervention was required to stop the bleeding.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) correction: the following information additional information received on (b)(6)-2021 was inadvertently omitted from 3500a initial medwatch report.The hemostasic valve (gasket) did not break into two or more separate pieces.The hemostatic valve did not become detached from the sheath.The sheath was not being used on the patient and there was no blood return.

Manufacturer Narrative

It was reported that during an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and a hemostatic valve separation issue occurred.Device investigation details: the device investigation has been completed which included a manufacturing record evaluation (mre).The manufacturing record evaluation was performed for the finished device 00001700 number, and no internal action related to the complaint was found during the review.Still no device has been received for analysis, therefore, no product investigation can be performed and the customer complaint cannot be confirmed.Based on the completed mre, the h4.Device manufacture date has been populated with 22-jun-2021.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: CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRVINE); 33 technology drive; irvine CA 92618
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12595986
• MDR Text Key: 281925077
• Report Number: 2029046-2021-01701
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2022
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2021
• 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: THMCL SMTCH SF BID, TC, D-F