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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 Problems Contamination /Decontamination Problem (2895); Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/04/2023
Event Type  malfunction  
Manufacturer Narrative
The product has not returned for analysis, however, pictures were provided by the customer.Evaluation is still in progress.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.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.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2023-01998 for product code d128211 (pentaray nav high-density mapping eco catheter).(2) mfr # 2029046-2023-01999 for product code d138502 (carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium).
 
Event Description
It was reported that a patient underwent a cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium which resulted with a visible small thread in the sheath.It was reported a very small thread was visible in the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium of which the origin of which could not be explained.The patient did not suffer any damage from these issues; there was no patient consequences.
 
Manufacturer Narrative
It was reported that a patient underwent a cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium which resulted with a visible small thread in the sheath.It was reported a very small thread was visible in the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium of which the origin of which could not be explained.The patient did not suffer any damage from these issues; there was no patient consequences.Device evaluation details: a picture was received from the customer to aid in the product investigation.The picture was evaluated following biosense webster's procedures.According to pictures provided by the customer, a thread of a foreign material was observed, it looks like the foreign material is polytetrafluoroethylene (ptfe); however, this cannot be conclusively at this time, the source of the foreign material cannot be determined at this time.A device history record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed based on the picture received.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.Note: h6.Investigation findings code of ¿appropriate term/code not available (c22)¿ used to represent the photo analysis results.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
On 27-oct-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.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 cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium which resulted with a visible small thread in the sheath.It was reported a very small thread was visible in the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium of which the origin of which could not be explained.The patient did not suffer any damage from these issues; there was no patient consequences.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual and dimensional inspection of the returned device was performed in accordance with bwi procedures.Visual inspection revealed that polytetrafluoroethylene (pt-fe) coating was found detached and exposed from the vizigo tip.The ptfe separation could be related to the interaction of the pentaray catheter and the sheath during introduction of the pentaray into the sheath however, this cannot be conclusively determined.A dimensional inspection was performed, and the device passed within specifications, however, the ptfe separation could be related with the resistance issue reported by the customer.A device history record was performed, and no internal actions related to the reported complaint were identified.The issues reported by the customer was confirmed.It should be noted that product failure is multifactorial.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 Key17687780
MDR Text Key322722083
Report Number2029046-2023-01999
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10846835016277
UDI-Public10846835016277
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,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
Report Date 11/07/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/05/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/26/2024
Device Catalogue NumberD138502
Device Lot Number60000133
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received11/01/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/27/2023
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
PENTARAY NAV ECO 7FR, D, 2-6-2
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