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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); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2022
Event Type  malfunction  
Manufacturer Narrative
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 reference number: (b)(4).
 
Event Description
It was reported that a patient underwent an ablation procedure with a carto vizigo¿ 8. 5f bi-directional guiding sheath ¿ small and a hemostatic valve separation issue occurred. The hemostatic valve was stiffer than usual, and the dilator could not be inserted (the dilator bent). The issue was resolved by changing the carto vizigo¿ 8. 5f bi-directional guiding sheath ¿ small to another one. Checked after retrieval to confirm that the hemostatic valve had come off into the handle and the hemostatic valve fell into the hub. The procedure was completed without patient's consequence. The hemostatic valve issue was assessed as mdr reportable for a hemostatic valve separation issue. The dilator unable to be inserted was assessed as not mdr reportable for an obstructed sheath issue. The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote. The dilator bent issue was assessed as not mdr reportable for a dilator damaged issue. The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.
 
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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
michelleann garcia
31 technology dr
irvine, CA 92618
6465917981
MDR Report Key14096502
MDR Text Key289753731
Report Number2029046-2022-00784
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10846835016253
UDI-Public10846835016253
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K170997
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2022
Device Model NumberD138501
Device Catalogue NumberD138501
Device Lot Number00001836
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received05/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/31/2021
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: 04/13/2022 Patient Sequence Number: 1
Treatment
SMARTABLATE IRR TUBE SET; UNKNOWN BRAND IRRIGATION TUBING; UNKNOWN BRAND PUMP; UNK_CARTO VIZIGO SHEATH
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