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

Model Number D138502

Device Problems Material Separation (1562); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 12/11/2020

Event Type  malfunction  

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 patient underwent cardiac ablation procedure for supraventricular tachycardia with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium where a hemostatic valve separation occurred.It was reported that the white valve missing from the handle of the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.Damage was discovered upon opening the sheath.The sheath was exchanged and the issue was resolved.The case continued without any further incident.There was no patient consequence reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The event was assessed as a mdr reportable hemostatic valve separation issue.

Manufacturer Narrative

The device evaluation was completed on 2/23/2021.It was reported that a patient underwent cardiac ablation procedure for supraventricular tachycardia with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium where a hemostatic valve separation occurred.It was reported that the white valve missing from the handle of the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium.Damage was discovered upon opening the sheath.The sheath was exchanged and the issue was resolved.The case continued without any further incident.There was no patient consequence reported.The device was not used.During the visual inspection, the hemostatic valve condition (dislodged) was confirmed.Additionally, during the microscopic analysis of the device, there was damage found in the hemostatic valve, which implies that the device was used.It was determined that the issue observed could be related to the incorrect insertion of the dilator into the sheath causing the dislodgment of the valve since microscope testing was performed and evidence of mechanical damage was observed on the hemostatic valve.This damage also suggests that the dilator had been tried to be introduced not in a straight position as indicated on the odp.According to the odp (optimal performance guide), there are some precautions on inserting the dilator into the vizigo sheath.Always insert a dilator straight into the center of the sheath¿s valve to prevent damage to the valve.Do not insert a dilator at an angle, as damage to the sheath valve may occur.A device history record evaluation was performed, and no internal action related to the complaint was found during the review.The customer complaint was confirmed.The root cause of the hemostatic valve separation could be related to the handling of the device during the procedure; however, this cannot be conclusively determined.The odp (optimal device performance guide) provides additional instructions on how to insert the dilator into the sheath.The root cause of the dislodged hemostatic valve could be related to handling of the device during the procedure; however, this cannot be conclusively determined.The odp (optimal device performance guide) provides additional instructions on how to insert the dilator into the sheath.Due to the conditions observed in the hemostatic valve, an internal corrective action has been opened to investigate.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 (b)(6) 2021, noted a correction to the 3500a initial.In the event it was reported that the event was assessed as a mdr reportable hemostatic valve separation issue.It should have stated, ¿the event is reportable due to the assessed mdr reportable hemostatic valve separation issue.The ¿out of box failure¿ that was included in the codes was to reflect the fact that this issue was identified immediately when the device was opened, and not during the procedure.In itself, the ¿out of box failure¿ is considered not mdr reportable.¿ therefore, h6.Medical device problem code of ¿manufacturing, packaging or shipping problem (a02)¿ has been processed.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on (b)(6) 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

Additional information was received on (b)(6) 2021 stating that the device was not used.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; 33 technology drive; irvine CA 92618
• MDR Report Key: 11137773
• MDR Text Key: 268150219
• Report Number: 2029046-2021-00010
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• Combination Product (y/n): N
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2021
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND SHEATH