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

Model Number D138502

Device Problems Break (1069); Entrapment of Device (1212); Patient Device Interaction Problem (4001)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/28/2021

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 an (b)(6) female patient underwent an atrial flutter left (l-afl) ablation procedure with a carto vizigo" 8.5f bi-directional guiding sheath  medium and issues of foreign body, broken tip and medical device entrapment  excessive manipulation required occurred which required surgical intervention and prolonged hospitalization.At the end of the case, it was noticed that the plastic coding on the tip of the sheath had exposed wires and the distal electrode was missing when it was taken out of the patients body.It was reported that the distal electrode of the sheath was in the adventitia of the femoral vein.This was noticed after the sheath was removed from the patient.There was difficulty removing the sheath and the physician was twisting the sheath back and forth to remove it.It was noticed there was an electrode missing from the sheath.They used fluoroscopy at the site, and it was verified under fluoroscopy.A vascular surgeon came to the room and removed the electrode from the patient.The patient was stable.The patient stayed overnight for observation.According to the vascular surgeon, the stick was low and was at a 90-degree angle and the sheath would have needed to make a steep bend to enter into the patient's body.The physician believes that the sheath was damaged due to scar tissue in the groin.He had difficulty placing all sheaths on that side.The vascular surgeon was called, a 2.5-3 cm incision was made, and the electrode was removed from the adventitia of the femoral vein.The surgeon also stated the femoral vein had been accessed instead of the common femoral vein.The patient fully recovered with no residual effects.The patient was admitted to the hospital and stayed an extra day.This event (foreign body) was assessed as mdr reportable.Since it might result in permanent impairment of a body function or permanent damage to a body structure; or it required medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.The broken tip was assessed as mdr reportable product malfunction since catheter integrity is not maintained and internal components are exposed to patient.The medical device entrapment  excessive manipulation required was assessed as mdr reportable product malfunction.Surgical intervention is required or a serious injury occurred, the event is reportable.

Manufacturer Narrative

An analysis of the pictures provided by the customer was completed on 6-oct-2021.It was reported that an 82-year-old (150 lbs) female patient underwent an atrial flutter left (l-afl) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and issues of foreign body, broken tip and medical device entrapment ¿ excessive manipulation required occurred which required surgical intervention and prolonged hospitalization.At the end of the case, it was noticed that the plastic coding on the tip of the sheath had exposed wires and the distal electrode was missing when it was taken out of the patient¿s body.It was reported that the distal electrode of the sheath was in the adventitia of the femoral vein.This was noticed after the sheath was removed from the patient.There was difficulty removing the sheath and the physician was twisting the sheath back and forth to remove it.It was noticed there was an electrode missing from the sheath.They used fluoroscopy at the site, and it was verified under fluoroscopy.A vascular surgeon came to the room and removed the electrode from the patient.The patient was stable.The patient stayed overnight for observation.According to the vascular surgeon, the stick was low and was at a 90-degree angle and the sheath would have needed to make a steep bend to enter the patient's body.The physician believes that the sheath was damaged due to scar tissue in the groin.He had difficulty placing all sheaths on that side.The vascular surgeon was called, a 2.5-3 cm incision was made, and the electrode was removed from the adventitia of the femoral vein.The surgeon also stated the femoral vein had been accessed instead of the common femoral vein.The patient fully recovered with no residual effects.The patient was admitted to the hospital and stayed an extra day.According to two pictures provided by customer, electrode was observed detached from the sheath, and the fluoroscopy picture shows the electrode inside patient body.The device history record evaluation (dhr) cannot be performed because no lot number was provided by the customer.The customer complaint was confirmed from the photo analysis.However, the device has not been returned for evaluation.Since no device has been received, no product investigation can be performed.If the device is received in the future, the product analysis will be performed as appropriate in order to find the root cause of the complaint.Explanation of codes: investigation findings: mechanical problem identified (c07)/ investigation conclusions: cause not established (d15) component code: tip (g04129) were selected as related to the broken tip.Investigation findings: no findings available (c20) / investigation conclusions: cause not established (d15) were selected as related to no device returned.H6.Investigation findings code of ¿appropriate term/code not available¿ represents photo/video 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
• MDR Report Key: 12363977
• MDR Text Key: 268035576
• Report Number: 2029046-2021-01388
• 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
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/28/2021
• Initial Date FDA Received: 08/25/2021
• Supplement Dates Manufacturer Received: 09/24/2021
• Supplement Dates FDA Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 68