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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
Catalog Number D138502
Device Problem Partial Blockage (1065)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/10/2023
Event Type  malfunction  
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 ¿ medium where in the sheath would not flush whenever the catheter was inside the sheath.It was reported that after connecting the iv tubing to the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium, the iv pump was displaying an error, and the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium would not flush.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was disconnected and manually flushed, and the caller confirmed the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was irrigating.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium would not flush whenever the stsf df catheter was inside the sheath.The iv pump was replaced without resolution.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was replaced and the issue resolved.The procedure continued.There was no patient consequence.Additional information received indicated there was no visible damage on the sheath or catheter.There was occlusion with only partial blocking when the iv pump tubing was hooked to the sheath.The sheath was able to be manually flushed, but fluid could not run through an iv pump.No resistance was felt and the issue was discovered after the sheath was inserted.
 
Manufacturer Narrative
On 31-aug-2023, 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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium where in the sheath would not flush whenever the catheter was inside the sheath.It was reported that after connecting the iv tubing to the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium, the iv pump was displaying an error, and the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium would not flush.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was disconnected and manually flushed, and the caller confirmed the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was irrigating.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium would not flush whenever the stsf df catheter was inside the sheath.The iv pump was replaced without resolution.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium was replaced and the issue resolved.The procedure continued.There was no patient consequence.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection, back pressure test, and microscopic examination of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.Microscopic examination of the hemostatic valve surface does not showed stress marks on the outer diameter.Then, a back pressure test was performed, and values were observed within specifications, no issues were observed.Neither leak, bubbles or air aspiration was observed.The device flush correctly, no irrigation issue was identify during the analysis.A device history record was performed, and no internal actions related to the reported complaint were identified.The issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instructions for use contain the following warning stated in the instructions for use (ifu): before inserting the sheath into the patient, flush the sheath and dilator with heparinized normal saline to remove air bubbles and any potential particulate.After the sheath is in the left atrium of the patient, maintain a constant flow of heparinized normal saline to the sheath to minimize the risk of air emboli.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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
kate karberg
31 technology dr
irvine, CA 92618
3035526892
MDR Report Key17703660
MDR Text Key322892698
Report Number2029046-2023-02031
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
Report Date 09/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/07/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberD138502
Device Lot Number60000177
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2023
Is the Reporter a Health Professional? No
Date Manufacturer Received09/18/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/09/2023
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
UNKNOWN IV PUMP; UNK_SMART TOUCH BIDIRECTIONAL SF
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