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

Model Number D138501

Device Problem Material Perforation (2205)

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

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

A device history record evaluation was performed for the finished device [00001433] number, and no internal action related to the reported complaint condition were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Initial reporter phone: (b)(6).Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - small where a perforation on a dilator occurred.After wire was inserted, when sheath was brought up from the inferior vena cava (ivc), there was a feeling that the wire was cut as if it were at the physician's hand.When it try to pull the wire, the outside of the wire on the head side comes off.The wire was collected from the ivc side with a snare without pulling it as it was at the doctor's discretion.The procedure was completed without patient's consequence.The event description and the image provided by the customer are not clear.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.With the available information this event is coded as perforation of the dilator by the guidewire.Should more information becomes available in the future; the reportability decision will be reassessed.

Manufacturer Narrative

On (b)(6) 2020, additional information was received indicating that ¿no difficulty experienced while maneuvering the catheter or during the withdrawal.¿ on (b)(6) 2021, 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 cardiac ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - small where a perforation on a dilator occurred.After wire was inserted, when sheath was brought up from the inferior vena cava (ivc), there was a feeling that the wire was cut as if it were at the physician's hand.When it try to pull the wire, the outside of the wire on the head side comes off.The [wire] was collected from the ivc side with a snare without pulling it as it was at the doctor's discretion.The procedure was completed without patient's consequence.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation and the evaluation has been completed.Bwi conducted visual inspection of the returned device.Visual analysis of the returned vizigo sample revealed that the guide wire was separated, the outside of the wire (the coil) came off, the head side (tip) present signs that it was used excessive force and that damaged it.A device history record was performed, and no internal actions related to the reported complaint were identified.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.Based on the information currently available, microscopic examination of the returned product indicates that the guidewire was subjected to excessive force.According to the odp (optimal performance guide), there are some precautions: during insertion over the guidewire, use caution not to create excessive bends in this device.This may inhibit advancement of the needle and may result in inadvertent needle puncture of the dilator/sheath assembly.Additionally, the customer provided a photo of the reported complaint device to aid in the investigation.However, the picture is not clear.It is not possible to identify which part of the catheter is shown in the picture.It does not provide sufficient information related to the reported event and therefore no result can be obtained from it.The customer complaint could not be confirmed from the picture.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.(b)(6) on 4/14/2021 it was noticed that the following information was inadvertently omitted from the respective fields in the 3500a supplemental (follow-up) #2.As such, the fields have now been populated accordingly: d9.Device available for evaluation? should have been ¿yes¿ d9.Is device returned to manufacturer? should have been ¿check marked¿ d9.Date device returned to manufacturer should have been 1/14/2021.

• 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: 11046486
• MDR Text Key: 225008385
• Report Number: 2029046-2020-01967
• 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: 11/25/2020

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: 08/27/2021
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 12/23/2020; 03/25/2021
• Supplement Dates FDA Received: 01/18/2021; 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1