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

Model Number D138502

Device Problem Material Separation (1562)

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

Event Date 12/03/2020

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.A manufacturing record evaluation was performed for the finished device 00001111 number, and no internal action related to the complaint was found during the review.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 for paroxysmal atrial fibrillation (afib) with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium where a hemostatic valve separation occurred.It was reported that when the dilator was introduced the hemostatic valve was very stiff with lots of resistance.Once dilator was in patient body the dilator bled blood back.The sheath was replaced, and the issue resolved.The valve did not break into pieces nor did it detach from the sheath.It is unknown if air entered the patient¿s body.Percutaneous or surgical removal was not required.The blood loss was 10-20ml, so hemodynamics was not compromised and medical intervention was not required.No report of patient consequence.Since the patient¿s hemodynamics was not compromised and no interventions were required to stop the bleed, this will not be considered a patient adverse event but a product malfunction.

• Brand Name: CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH MEDIUM
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRVINE); 33 technology drive; irivine CA 92618
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11099701
• MDR Text Key: 250524134
• Report Number: 2029046-2020-02024
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2021
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001111
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2019
• 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