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

Model Number D138503

Device Problem Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/07/2020

Event Type  malfunction  

Manufacturer Narrative

The biosense webster inc.Product analysis lab received the device for evaluation.Upon initial inspection, the hemostatic valve was observed dislodged, with the brim cap detached.The observed findings coincide with what was initially reported.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.A manufacturing record evaluation was performed for the finished device and no internal actions were found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for idiopathic ventricular tachycardia (idvt) with a carto vizigo¿ 8.5f bi-directional guiding sheath - large and a hemostatic valve separation issue occurred.It was reported that during a left sided premature ventricular contraction (pvc) ablation procedure, after the carto vizigo sheath was inserted, the hemostatic valve came off and there was some blood back flow.The sheath was taken out and was replaced with a new one.The case continued and no further issues were reported.There¿s no indication that the blood leakage led to hemodynamic disruption or that medical/surgical intervention was required.It was indicated that no air entered to the patient.A picture was provided by the customer and it can be confirmed the brim cap was also detached from the sheath.The observed hemostatic valve separation has been assessed as an mdr reportable malfunction.

Manufacturer Narrative

Initially we reported, ¿there¿s no indication that the blood leakage led to hemodynamic disruption or that medical/surgical intervention was required.¿ additional information was received on june 8, 2020 on the event confirming that the patient¿s hemodynamics was not compromised due to the blood leakage.No medical/surgical intervention was required.In addition, during an internal review on (b)(6) 2020, a correction was noted to the "d1.Brand name".Therefore, this field has been re-populated.It was reported that a patient underwent an ablation procedure for idiopathic ventricular tachycardia (idvt) with a carto vizigo¿ 8.5f bi-directional guiding sheath - large.It was reported that during a left sided premature ventricular contraction (pvc) ablation procedure, after the carto vizigo sheath was inserted, the hemostatic valve came off and there was some blood back flow.The sheath was taken out and was replaced with a new one.The case continued and no further issues were reported.Patient¿s hemodynamics was not compromised due to the blood leakage.No medical/surgical intervention was required.It was indicated that no air entered to the patient.A picture was provided by the customer and it can be confirmed the brim cap was also detached from the sheath.The investigation summary was completed on (b)(6) 2020.According to the picture provided by the customer, the brim cap, hemostatic valve and friction ring were detached from the hub of the carto vizigo¿ 8.5f bi-directional guiding sheath - large.The customer complaint was confirmed.The product analysis was performed as appropriate in order to find the root cause of the complaint.Device investigation summary: the returned device was visually inspected and it was found that the brim cap had been detached and the hemostatic valve had been dislodged.A second closer inspection was performed and the brim cap, the hemostatic valve and silicone ring were found detached from the hub.No other damages were observed on the device.Adhesive was normally applied to bond the clear hub and the brim cap.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.The customer complaint was confirmed.The root cause of the damage on the hemostatic valve and brim cap detached from the hub could be related to handling of the device during the procedure.However, this cannot be conclusively determined.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

• Brand Name: CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - LARGE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 10126299
• MDR Text Key: 202035377
• Report Number: 2029046-2020-00665
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835016260
• UDI-Public: 10846835016260
• 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: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2020
• Device Model Number: D138503
• Device Catalogue Number: D138503
• Device Lot Number: 00001178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Date Manufacturer Received: 06/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1