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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 ¿ LARGE; INTRODUCER, CATHETER

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BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ LARGE; INTRODUCER, CATHETER Back to Search Results
Model Number D138503
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2022
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone: (b)(6).As stated in the complaint form, the event date is unknown.The bwi product analysis lab received the device for evaluation (b)(6)2022.The device evaluation was completed on (b)(6)2022.The product was returned to biosense webster for evaluation.Visual analysis of the returned sample revealed that the hemostatic valve was found dislodged inside the hub of the vizigo sheath.A dilator was introduced with the hemostatic valve dislodged, and resistance was found.Then the hemostatic valve was taken off the hub, the dilator was introduced again, and no resistance was found.A microscopic examination of the hemostatic valve surface showed evidence of damage to the outer diameter.The dilator outer diameter was measured, and dimensions were found within specifications.The hemostatic valve dislodged could be related to the resistance reported by the customer.A device history record was performed, and no internal actions related to the reported complaint were identified.The issue reported by the customer was confirmed.The odp (optimal device performance guide) contains the following caution: always insert a dilator straight into the center of the sheath¿s valve to prevent damage to the valve.Do not insert a dilator at an angle, as damage to the sheath valve may occur.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.Manufacturer's reference number: (b)(4).
 
Event Description
It was reported that a patient underwent a procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - large and the biosense webster inc.Product analysis lab observed a hemostatic valve separation issue.Initially it was reported that the dilatator of the vizigo sheath was not insertable.The event occurred during sterile processing.The event occurred during field inspection.No patient consequence was reported.Additional clarification was requested and the response was received.The dilator was not insertable due to resistance.No physical damage on the sheath or dilator.There was no occlusion when irrigating the sheath.The sheath was narrowed.It was not possible to move the dilator inside the sheath.The event was assessed as not mdr reportable for a resistance with sheath issue.Interference or friction between devices is a known occurrence.If resistance is encountered, the system may be withdrawn as a unit.This is a common practice during procedures.Since the vast majority of ep procedures utilize multiple device exchanges, an increased potential for patient injury is remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6)2022 the hemostatic valve was found dislodged inside the hub of the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large.The returned condition was assessed as mdr reportable for a hemostatic valve separation issue.The awareness date for this reportable lab finding was (b)(6)2022.
 
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Brand Name
CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ LARGE
Type of Device
INTRODUCER, 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
kate karberg
31 technology dr
irvine, CA 92618
3035526892
MDR Report Key15697455
MDR Text Key304819668
Report Number2029046-2022-02688
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10846835016260
UDI-Public10846835016260
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,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 10/30/2022
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 Date04/11/2023
Device Model NumberD138503
Device Catalogue NumberD138503
Device Lot Number00001965
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/01/2022
Initial Date FDA Received10/30/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/11/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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