MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM; INTRODUCER, CATHETER

Model Number D138502

Device Problems Entrapment of Device (1212); Failure to Advance (2524); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device problem code of ¿appropriate term code/no code available (a27)¿ represents the issue of the rough surface of the sheath.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 ¿ medium and an issue of rough surface of the sheath occurred.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium can be moved only under strong pressure in the vein.The surface of the sheath was rough and not slippery.No patient consequence was reported.Additional information was received on the event.There was no resistance with vasculature or lack of flow.There was physical roughness on the sheath shaft.There was no damage inflected to the patient due to the resistance.The roughness did not cause any consequence to the patient.Opinion is that there was poor nonstick coating of the shaft and a significant surface unevenness due to the metal mesh under the surface.The medical device entrapment was assessed as not mdr reportable.The device was removed without surgical intervention, or without using a different device, the potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.The reported rough surface of the sheath was assessed as mdr reportable.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 21-aug-2021.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on 27-aug-2021, a correction was made to the assessment of this event.The rough surface of the sheath that was originally reported as the reportable malfunction, was reassessed to not mdr reportable as an explanation was being requested on clarification of the issue.The additional information provided on 13-aug-2021 describing that there was poor nonstick coating of the shaft and a significant surface unevenness due to the metal mesh under the surface was assessed as a mdr reportable issue.Therefore, ¿g3.Date received by manufacturer¿ should have been processed as 13-aug-2021.In addition, a correction to ¿h10.Additional manufacturer narrative¿ as it stated: ¿h6.Medical device problem code of ¿appropriate term code/no code available (a27)¿ represents the issue of the rough surface of the sheath.¿ it should have stated: ¿h6.Medical device problem code of ¿appropriate term code/no code available (a27)¿ represents the issue of , ¿there was poor nonstick coating of the shaft and a significant surface unevenness due to the metal mesh under the surface.¿.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) in the 3500a follow-up #2 it reflects, ¿h6.Medical device problem code of ¿appropriate term code/no code available (a27)¿ represents the issue of , ¿there was poor nonstick coating of the shaft and a significant surface unevenness due to the metal mesh under the surface¿.¿ after further review on 03-nov-2021, a correction to the h6.Medical device problem code for this issue is ¿failure to advance (a150204)¿.Therefore, processed this field.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.The carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium can be moved only under strong pressure in the vein.The surface of the sheath was rough and not slippery.No patient consequence was reported.Additional information was received on the event.There was no resistance with vasculature or lack of flow.There was physical roughness on the sheath shaft.There was no damage inflected to the patient due to the resistance.The roughness did not cause any consequence to the patient.Opinion is that there was poor nonstick coating of the shaft and a significant surface unevenness due to the metal mesh under the surface.The device evaluation was completed on (b)(6)-2021.The catheter was returned to biosense webster for evaluation.Bwi conducted a visual inspection, an outer diameter (od) test and an insertion withdrawal test of the returned device.Visual inspection revealed that the sheath had several bents at the distal part.The dilator was not returned.An od test was performed and the sheath passed the specification.Also, an insertion withdrawal test was performed and the sheath failed, since sheath had several bents.All units are inspected prior leaving the facility to avoid this type of damaged prior leaving the manufacturing site.It could be related to excessive force or manipulation; however, it cannot be conclusively determined.A device history record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of bwi's quality process, all devices are manufactured, inspected, and released to approved specifications.The instructions for use (ifu) states the following precaution: "careful manipulation must be performed in order to avoid cardiac damage, perforation, or tamponade.Catheter advancement and placement through a guiding sheath should be done using a combination of visual aids available, fluoroscopic guidance and/or intracardiac ultrasound.Intracardiac signals are not recorded from electrodes placed on the sheath.In addition, extra care should be taken while inserting, aspirating, and manipulating the guiding sheath".The resistance with sheath was confirmed, due to the several bents found.However, the outer diameters were found within specification.The root cause of the resistance in the vein remains unknown.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported ¿rough surface of the sheath¿.Investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the customer¿s reported medical device entrapment.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12340590
• MDR Text Key: 267243938
• Report Number: 2029046-2021-01364
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/05/2021

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 Date: 05/10/2022
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/28/2021
• Initial Date FDA Received: 08/19/2021
• Supplement Dates Manufacturer Received: 08/21/2021; 08/27/2021; 11/03/2021; 11/04/2021
• Supplement Dates FDA Received: 08/25/2021; 09/14/2021; 11/04/2021; 11/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1