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

Model Number D138501

Device Problems Entrapment of Device (1212); Device-Device Incompatibility (2919); Material Protrusion/Extrusion (2979); Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Foreign Body In Patient (2687)

Event Date 07/25/2022

Event Type  Injury  

Event Description

It was reported that an unknown patient underwent a atrial fibrillation ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - small.The patient suffered device entrapment, requiring surgical intervention; an electrode detached, and internal components were exposed.While putting the sheath into the patient, the hcp said, it is hard to insert the mandrain (needle).Then he got it.Post op, when the hcp wanted to pull out the sheath, it was stuck in the patient and it did not go out.Another doctor had to help; the sheath was stuck.When they were able to pull it out, fragments of the distal end were gone off, but were saved and out of the patient.The patient did not experience a post-op device malfunction.Other medical intervention was required, the wound ( access site) had to be enlarged, then it was sewn up, the patient is not part of a clinical study.There was a resistance between dilator and sheath.The doctor described it as an mandrain (he used this word for the needle).The resistance was between dilator and sheath.There was no occlusion when irrigating the sheath, and the doctor used it as normal.The sheath was narrowed.To remove the sheath, the doctor had to cut the body access about 2mm more at normal procedure.No special items were necessary.To remove the fragments nothing was needed.The one and only item came out alone by pulling the sheath.The damage resulted in outlayer wires being partially torn.The proximal electrode ring is lifted and detached.The detachment was total.The section removed from the sheath when it was pulled out of the patient and fell to the table.No patient consequences confirmed.Resistance with sheath is not mdr-reportable.Medical device entrapment with excessive manipulation required is mdr-reportable.Electrode damage resulting in sharp rough edges is mdr-reportable.Exposure of internal components is mdr-reportable.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.However, a picture was received for evaluation following biosense webster's procedures.Device investigation details: according to pictures provided by the customer, an electrode of the vizigo sheath was detached completely, this condition could be related to the manipulation of the device during the removal, since according to the additional information provided the sheath was narrowed and the only item came out alone by pulling the sheath.The damage resulted in outlayer wires being partially torn.The proximal electrode ring was lifted and detached.The detachment was total.A manufacturing record evaluation was performed for the finished device number 00001985 and no internal action related to the complaint was found during the review.The customer complaint was confirmed based on the picture received.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.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

On 22-aug-2022, bwi received additional information regarding the event.While discussing questions for the complaint, the physician studied the patient history and found out that the patient had a stroke one day later.In the opinion of the physician, the stroke was not caused by the incident with the sheath.On 24-aug-2022, bwi received further information.The physician¿s opinion on the cause of this event is that it was due to bwi product malfunction.The patient outcome of the event is unchanged.The patient required extended hospitalization because of the event; the physician studied the patient history and found out that the patient had a stroke one day later.There were no relevant tests/laboratory data.Other relevant history includes: kidney carcinoma; abdominal aneurysm; circulatory disorders in the legs.Per the new information, the section b2 checkbox for hospitalization initial/prolonged was selected due to the prolonged hospitalization.Additionally, the h6 clinical code for "stroke/cva" (e0133) was added to the event due to the patient's stroke.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

On 15-nov-2022, a photograph was evaluated and analyzed by the bwi product analysis lab.The physical device was also subsequently analyzed/evaluated.It was reported that an unknown patient underwent a atrial fibrillation ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - small.The patient suffered device entrapment, requiring surgical intervention; an electrode detached, and internal components were exposed.Device evaluation details: a picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, an electrode of the vizigo sheath was detached completely, this condition could be related to the manipulation of the device during the removal, since according to the additional information provided the sheath was narrowed and the only item came out alone by pulling the sheath.The damage resulted in outlayer wires being partially torn.The proximal electrode ring was lifted and detached.The detachment was total.The product was returned to biosense webster for evaluation.A visual and dimensional inspection was performed following bwi procedures.Visual inspection was performed, and one electrode was observed detached from its place, in addition, another electrode was observed lifted with internal components exposed along the shaft.The dilator was inspected, and a bent was observed.The dilator and a good known lab sample catheter were introduced through the sheath, and resistance was felt.The dilator's outer diameter was measured, and dimensions were found within specifications.Due to the resistance issue, an internal action was opened.The damage reported by the customer could be related to the usage of the device during the procedure (entrapment).The instructions for use (ifu) contain the following recommendations: move the catheter carefully to avoid cardiac damage, perforation, or tamponade.If resistance is encountered, do not use excessive force to advance or withdraw the catheter through the sheath.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.Device history record evaluation was performed for the finished device number 00001985 and no internal action related to the complaint was found during the review.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

On 17-oct-2022, the bwi product analysis lab received the device for evaluation.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; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRVINE); 33 technology drive; irvine CA 92618
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15262543
• MDR Text Key: 298282308
• Report Number: 2029046-2022-01918
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/12/2022

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: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/26/2022
• Initial Date FDA Received: 08/19/2022
• Supplement Dates Manufacturer Received: 09/21/2022; 10/17/2022; 11/15/2022
• Supplement Dates FDA Received: 09/12/2022; 11/09/2022; 12/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization