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

Model Number D138502

Device Problem Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2020

Event Type  malfunction  

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath, and the biosense webster inc.(bwi) product analysis lab (pal) found the brim cap separated from the hub.Initially it was reported that the hub of the vizigo sheath broke off while prepping.The caller replaced the sheath and the case continued without patient consequences.No adverse patient consequences were reported.The observed hemostatic valve damage has been assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.On 3/2/2020, the bwi pal received the device for evaluation.Upon initial inspection, the bwi pal observed the brim cap separated from the hub.The observed brim cap separated from the hub has been assessed as an mdr reportable malfunction.The awareness date has been reset to 3/24/2020.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath, and the biosense webster inc.(bwi) product analysis lab (pal) found the brim cap separated from the hub.Initially it was reported that the hub of the vizigo sheath broke off while prepping.The investigational analysis completed 4/23/2020.The device was visually inspected and brim cap, valve, and friction ring were found dislodged into hub.These components could have been detached due to an external force while inserting the device thru the sheath, but this could not be conclusively determined.A manufacturing record evaluation was performed for the finished device, and no internal actions were found during the review.The customer complaint was confirmed.The root cause of the brim cap and detached hemostatic valve cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures.It could be related to the handling of the device during the procedure.However, this cannot be conclusively determined.Manufacture reference no: (b)(4).

Manufacturer Narrative

During an internal review on (b)(6) 2020, the initially reported event of ¿the hub of the vizigo sheath broke off while prepping¿ was inadvertently assessed as not mdr reportable for a hemostatic valve damage issue.However, after further review, this issue was corrected to reflect as a reportable hemostatic valve separation issue.Therefore, below is a corrected b5.Event description: ¿it was reported that a patient underwent an ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath, and a hemostatic valve separation issue occurred.Initially it was reported that the hub of the vizigo sheath broke off while prepping.The caller replaced the sheath and the case continued without patient consequences.No adverse patient consequences were reported.This issue was assessed as an mdr reportable event where the hemostatic valve integrity was disrupted and therefore, considered a reportable hemostatic valve separation.On (b)(6) 2020, the biosense webster, inc.Product analysis lab received the device for evaluation.Upon initial inspection, the bwi pal observed the brim cap separated from the hub assembly.Both the brim cap detachment and the separation of the hemostatic valve can be viewed as parts of the same failure compromising the integrity and function of the hemostatic valve dysfunctional and can be considered as capturing the same event.Therefore, this issue remains assessed as mdr reportable.¿ per the correction to the reportability assessment, there is a correction to the 3500a initial ¿g4.Date received by manufacturer¿ from 3/24/2020 to 3/10/2020.In addition, the following corrections were identified to the 3500a initial: ¿b1.Brand name¿ should have reflected carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium; however, processed as 8.5f sheath with curve viz mdc.¿d10.Device available for evaluation?¿ should have reflected as yes; however, processed as no.¿g1.Manufacturer contact addr.St.Line 1¿ should have reflected as 31 technology drive; however, processed as 33 technology drive.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).

• Brand Name: CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9970963
• MDR Text Key: 201945180
• Report Number: 2029046-2020-00555
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2020
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001212
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/24/2020
• Date Manufacturer Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SOUNDSTAR ECO CABLE ASSY 10 FT.; SOUNDSTAR ECO SMS 10F CATHETER.