MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. 8.5F SHEATH WITH CURVE VIZ MDC; INTRODUCER, CATHETER

Model Number D138502

Device Problems Backflow (1064); Display or Visual Feedback Problem (1184); Entrapment of Device (1212)

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

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been reported as discarded, 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.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 ref.# (b)(4).

Event Description

It was reported that a patient underwent cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small where air in the hemostatic valve occurred.It was reported that air was observed inside the hub of the carto vizigo¿ 8.5f bi-directional guiding sheath - small several times.It was also reported that the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small was trapped slightly in the femoral [vein].It was also reported that left pulmonary vein isolation (lpvi) middle diagonal line appeared and disappeared repeatedly for some reason even though the calibration was quite good.The issues of the device entrapment and visualization issue are not considered to be mdr reportable since the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The risk to the patient is remote.The device was removed without surgical intervention, or without using a different device.The procedure was completed without patient's consequence.

Manufacturer Narrative

On (b)(6) 2020, biosense webster inc.Received additional event information that indicated that the complaint device was used on the patient.There was no breakage or separation of the hemostatic valve.No intervention was required.It was also reported that the sheath had resistance when it was inserted into the femoral vein, and it was not entrapped.Device investigation details: the device investigation has been completed which included a manufacturing record evaluation (mre).The manufacturing record evaluation performed for the finished device with lot number 00001273 identified no internal actions related to the reported complaint condition.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 (b)(6)2020.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: 8.5F SHEATH WITH CURVE VIZ MDC
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 11016553
• MDR Text Key: 252294953
• Report Number: 2029046-2020-01948
• Device Sequence Number: 1
• Product Code: DYB
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2021
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001273
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 12/20/2020
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1