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U.S. Department of Health and Human Services

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

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BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL INTRODUCER, CATHETER Back to Search Results
Model Number D138501
Device Problems Material Separation (1562); Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(6). 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. Manufacturer's reference number: (b)(4).
 
Event Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8. 5f bi-directional guiding sheath ¿ small and a hemostatic valve separation issue occurred. It was not possible to insert the dilator into the sheath. Visible damage (displacement) of sheath's valve. The part that was separated was the transparent valve of the sheath, a white part (probably the entering part of the valve) was visible. It was probably pushed into the transparent part. The sheath was not used on the patient because of a complete block and the dilator was not insertable. Therefore, the sheath was not used on the patient. This sheath was replaced with another one and from the same type, so that procedure was ended successfully. There were no patient consequences.
 
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Brand NameCARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ SMALL
Type of DeviceINTRODUCER, 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 Key13608008
MDR Text Key289327623
Report Number2029046-2022-00386
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10846835016253
UDI-Public10846835016253
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K170997
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/04/2022
Device Model NumberD138501
Device Catalogue NumberD138501
Device Lot Number00001745
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/15/2022
Is the Reporter a Health Professional? No
Date Manufacturer Received03/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/04/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/25/2022 Patient Sequence Number: 1
Treatment
UNK BRAND SHEATH
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