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

Model Number D138502

Device Problems Device-Device Incompatibility (2919); Material Deformation (2976); Mechanical Jam (2983); Patient Device Interaction Problem (4001)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 02/04/2022

Event Type  Injury  

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).

Event Description

It was reported that a male patient underwent a redo pulmonary vein isolation (pvi) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.There was tissue on the wire when it was removed.During the procedure when inserting the dilator into the sheath, exceptional force was required to inserted the dilator into the sheath.When the dilator was almost inserted it folded (bent).The surgical team proceeded as normal, but it was a difficult puncture.The guide wire in the sheath resulted in a knot, and the team was unable to retrieve the wire into the dilator.The dilator was removed but also unable to retrieve the wire into the sheath.A second sheath opened and a second wire placed and they were able to remove the sheath with the first wire in one attempt.It was noted that on the wire there was a small amount of tissue is visible.The procedure was completed normally with the second sheath.The resistance they were having with the sheath occurred while inserting the dilator into the sheath.The sheath was no occluded but was reported as narrowed.They also attempted to insert the needle into the dilator.The dilator folding (bent) did not result in wires being exposed or any lifted or sharp rings.A catheter was not inserted into the first sheath.The bend was near the proximal end of the dilator.The physician¿s opinion on the cause of this adverse is the procedure.The sheath removed and exchanged for a different one.The patient was reported as fully recovered and did not require extended hospitalization.No clinical symptom were observed.Dilator damaged is not mdr-reportable.Resistance with sheath is not mdr-reportable.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

On 18-mar-2022, the bwi product analysis lab received the device for evaluation.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

On 13-apr-2022, bwi received additional information indicating that the wire in question is related to wire on vizigo sheath.The guidewire that was used is unknown.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

Per internal review completed on (b)(6) 2022, it was determined that due to the stuck guidewire, the "mechanical jam" (a0506) medical device problem code was added to this complaint.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

On 1-dec-2022, the product investigation was completed.It was reported that a male patient underwent a redo pulmonary vein isolation (pvi) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.There was tissue on the wire when it was removed.Device evaluation details: a picture showing reddish material on a catheter and another picture showing the sheath with a puncture were received for analysis.Even when the photos are related to the described event, they do not provide enough information, and no conclusion can be made.Visual analysis revealed that the shaft was folded in the transition from the handle to the shaft, and some bents were observed on the dilator; this condition could be related to the excessive force applied during the procedure.The dilator and a good known lab sample catheter were introduced through the sheath, and resistance was felt in the shaft bent area.No obstructions were detected.The dilator outer diameter was measured, and dimensions were found within specifications.The visualization on carto 3 and electrical features were tested, and no issues were observed.In addition, the product was deflecting and irrigating correctly.Device history records review was performed for the finished device 50000029 number, and no internal actions related to the complaint were found during the review.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.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: 13614946
• MDR Text Key: 289896454
• Report Number: 2029046-2022-00397
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2022
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 50000029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2021
• 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
• Treatment: SMARTABLATE GENERATOR.
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Male