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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 ¿MEDIUM; INTRODUCER, CATHETER
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BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿MEDIUM; INTRODUCER, CATHETER Back to Search Results
Model Number D138502
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/06/2022
Event Type  malfunction  
Manufacturer Narrative
Device investigation details: a picture was received as provided by the customer to aid in the investigational analysis.An evaluation was performed following biosense webster's procedures.According to the picture provided by the customer, a foreign material stain was observed on the cardboard tray, at this time it is not possible to determine the origin of the foreign material, however, if the device is returned in the future, a further investigation will be performed.A device history record was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer was confirmed based on the picture received.The device has not been returned for analysis and is not possible to assign a root cause based on the current evidence.If the device is received in the future, the product investigation will be performed and updated accordingly.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Investigation findings code of ¿appropriate term/code not available¿ represents photo/video analysis.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 a paroxysmal atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿medium and an issue of foreign material was encountered.After opening the carto vizigo¿ 8.5f bi-directional guiding sheath ¿medium, there was a residue or fluid inside the packaging and on the dilator of the carto vizigo¿ 8.5f bi-directional guiding sheath ¿medium.They replaced the carto vizigo¿ 8.5f bi-directional guiding sheath ¿medium and the procedure continued.The issue was noticed before use.The foreign material was described as clear and oily.The sheath was not used on the patient.It is unknown how device was contaminated, residue was discovered immediately after opening packaging.No fluids had been dropped in the sterile field yet and the scrub had new and dry gloves on.
 
Manufacturer Narrative
On 10-aug-2022, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.# (b)(4).
 
Manufacturer Narrative
It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿medium and an issue of foreign material was encountered.After opening the carto vizigo¿ 8.5f bi-directional guiding sheath ¿medium, there was a residue or fluid inside the packaging and on the dilator of the carto vizigo¿ 8.5f bi-directional guiding sheath ¿medium.They replaced the carto vizigo¿ 8.5f bi-directional guiding sheath ¿medium and the procedure continued.The issue was noticed before use.The foreign material was described as clear and oily.The sheath was not used on the patient.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Bwi conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the carto vizigo¿ 8.5f bi-directional guiding sheath ¿medium.The device was returned without its original package, therefore, an analysis to identify the composition the residue observed by the customer could not be performed.A manufacturing investigation was initiated with the supplier.However, information about the origin of the residue observed on the packaging card during the procedure is not manufacturing-attributable.As the packaging was not returned, the residue cannot be confirmed.A device history record evaluation was performed, and no internal action related to the reported complaint condition were identified.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.Note: h6.Investigation findings code of ¿appropriate term/code not available (d17)¿ used to represent the inability to analyze the product returned based on the returned condition.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
 
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Brand Name
CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿MEDIUM
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
michelleann garcia
31 technology dr
irvine, CA 92618
646591-798
MDR Report Key15127327
MDR Text Key304441778
Report Number2029046-2022-01746
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10846835016277
UDI-Public10846835016277
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170997
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 12/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/11/2023
Device Model NumberD138502
Device Catalogue NumberD138502
Device Lot Number00001933
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received11/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/11/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
8.5F SHEATH WITH CURVE VIZ MDC
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