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

Model Number D138501

Device Problems Break (1069); Material Protrusion/Extrusion (2979)

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

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

The product has not returned for analysis, however, a picture was 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.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 atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small.The tip was broken and there was an electrode that was damaged with sharp edges.After the procedure, when removed from the patient¿s body, the coating had peeled off of the tip and it was described in a condition like fluff.The procedure was completed without patient consequence.Additional information was received as requested.There was no resistance during use or removal within the vasculature.The damage was at the ring.The tip can not be described as soft.On review of the photo that was provided, the electrode appears lifted.In addition, the analysis of the photo provided confirmed the silicon coating between electrode 1 and tapered distal tip was observed peeled off.The electrode issue was assessed as mdr reportable for electrode damage with sharp edges.The issue with the tip was assessed as mdr reportable for broken tip.

Manufacturer Narrative

H6. investigation findings code of ¿appropriate term/code not available¿ represents photo/video analysis.  it was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small.The tip was broken and there was an electrode that was damaged with sharp edges.After the procedure, when removed from the patient¿s body, the coating had peeled off of the tip and it was described in a condition like fluff.The procedure was completed without patient consequence.Additional information was received as requested.There was no resistance during use or removal within the vasculature.The damage was at the ring.The tip can not be described as soft.On review of the photo that was provided, the electrode appears lifted.In addition, the analysis of the photo provided confirmed the silicon coating between electrode 1 and tapered distal tip was observed peeled off.The investigation was completed on 5/20/2021.An analysis was performed on the pictures that were provided by the customer.According to the pictures provided, the silicon coating between electrode 1 and tapered distal tip is observed peeled off.The customer complaint was confirmed.This investigation was performed based only on the photo provided.The product analysis was performed as appropriate in order to find root cause of the complaint.The product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and outer diameter measurement of the returned catheter.Visual analysis of the returned sample revealed the shaft was folded and it was found that the silicon coating peeled off, and the electrode 1 lifted.This issue left some internal parts exposed.The outer diameter of the electrode damaged did not pass the test.At this time, is not possible to determine the root cause of this condition; however, based on the information provided, the condition reported have origin during the procedure.The procedure was completed without patient's consequence.A device history record evaluation was performed, and no internal actions related to the reported complaint condition were identified.As part of bwi¿s quality process, all catheters are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.According to the odp (optimal performance guide), there are some precautions on the use of the vizigo sheath: inspect all components before use.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 5/30/2021, noted correction to follow-up #1.In "h10.Additional manufacturer narrative" it was reported, ¿the bwi product analysis lab received the device for evaluation on 4/9/2021.¿ however, in error the following fields were not processed: d9.Device available for evaluation?; d9.Date device returned to manufacturer; d9.Is device returned to manufacturer?.Therefore, processed these fields.

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).

• Brand Name: CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH SMALL
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11631768
• MDR Text Key: 266106256
• Report Number: 2029046-2021-00538
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2021
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Date Manufacturer Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1