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

Patient Problem Foreign Body In Patient (2687)

Event Date 10/25/2021

Event Type  Injury  

Event Description

It was reported that an unknown patient underwent an unknown ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small.The sheath was unable to be removed and surgical intervention was required.After the procedure was ended, when the vizigo was removed from the patient¿s body, the sheath caught in the inguinal ligament and could not be pulled out.Because there was no other way but to pull it out, the electrode part of the sheath came off and remained in the body when it was pulled out strongly.Then, it was surgically removed.According to the physician¿s comment, tweezers was used to pick the electrode from body, so the electrode is crushed.(through the fluoroscope, it seem that the ring shape was maintained).The medical device entrapment is mdr-reportable.The electrode damage leaving sharp edges is mdr-reportable.The broken tip is mdr-reportable.Since the event is life threatening and might result in permanent impairment of a body function or permanent damage of a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

Initial reporter phone: (b)(6).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 30-nov-2021, bwi received additional information regarding the event.The physician commented that the cause of the catching was a considerable resistance at the stage of inserting.When the sheath of a pvi had been inserted into the inguinal ligament.However, it is not uncommon, a sense of increasing resistance was evident, even more gradually, from the time the normal pvi sheath operation was performed.It is considered that the tightening at the inguinal ligament became stronger.When pulling it out finally, it was pulled out with a considerable force, but the electrode finally got caught and might have come off.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 29-nov-2021, 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).

Manufacturer Narrative

On 16-dec-2021, bwi received additional information regarding the event.It was indicated that the patient's hospitalization was prolonged compared to usual; however, a company representative heard that the patient has already been discharged from the hospital.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 11-jan-2022, the product investigation was completed.It was reported that an unknown patient underwent an unknown ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small.The sheath was unable to be removed and surgical intervention was required.After the procedure was ended, when the vizigo was removed from the patient¿s body, the sheath caught in the inguinal ligament and could not be pulled out.Because there was no other way but to pull it out, the electrode part of the sheath came off and remained in the body when it was pulled out strongly.Then, it was surgically removed.According to the physician¿s comment, tweezers was used to pick the electrode from body, so the electrode is crushed.(through the fluoroscope, it seem that the ring shape was maintained).Device evaluation details: according to pictures provided by the customer, one of the electrodes was damaged and it was separated from the rest of the sheath.Visual analysis of the returned sample revealed that electrode #1 was detached and it was found the silicon coating peeled off, this issue lave some internal parts exposed.The outer diameter of electrodes #2 to #4 was measured and it was found within specifications.At this time is not possible to determine the root cause of this condition, however, based on the information provided, the condition reported has origin during the procedure.A device history record was performed for the finished device 00001699 number, and no internal action related to the complaint was found during the review.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.Additional investigation was initiated to address the root cause of the ring detachment issue.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 (b)(6) 2022, the product investigation was updated after further inspection.It was reported that an unknown patient underwent an unknown ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small.The sheath was unable to be removed and surgical intervention was required.Device evaluation details: the detached electrode was also returned, it was visually inspected under magnification and show that it is deformed with dents, bends and pointed edges.Closer inspection shows that the area of the missing electrode and pebax margins appear to be acceptable.The catheter presented deep scratches on the distal tip; indicative of excessive force being applied.Additionally, tensile test through was performed and the results suggests that when excessive mechanical pull force was applied to the device.This demonstrated that the electrode was dislodged from the original location by excessive force applied.The investigation concluded based on the visual inspection that there was no manufacturing defect.A device history record was performed for the finished device 00001699 number, 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).

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12801745
• MDR Text Key: 280689147
• Report Number: 2029046-2021-01952
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: 10846835016253
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/13/2022

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 Expiration Date: 06/19/2022
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/25/2021
• Initial Date FDA Received: 11/12/2021
• Supplement Dates Manufacturer Received: 11/28/2021; 11/30/2021; 11/30/2021; 12/16/2021; 01/21/2022; 08/25/2022
• Supplement Dates FDA Received: 11/30/2021; 12/10/2021; 12/16/2021; 01/04/2022; 01/31/2022; 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2021
• 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): Life Threatening; Required Intervention