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

Model Number D138501

Device Problems Backflow (1064); Communication or Transmission Problem (2896); Temperature Problem (3022)

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

Event Date 03/25/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).The biosense webster, inc.Product analysis lab received the device 05/04/2021 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.Manufacturer's reference number: pc-(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small and an issue with air flowing back into the side port occurred.Initially, it was reported that when the thermocool® smart touch® sf bi-directional navigation catheter (stsf lot 30479620m) was connected to the carto 3 system, temperature was not displayed.The catheter was replaced with another stsf (lot #30479663m) and it was not recognized on the carto 3.The catheter was replaced, and the issue was resolved.It was also reported that after the sheath was inserted, error lined from sample port.The sheath was replaced and the issue was resolved.The procedure was completed without patient consequence.On 4/25/2021, additional information was received clarifying that after the sheath was inserted, bubble was introduced from the side port.It was not reported that air entered the patient¿s body.Percutaneous or surgical removal were not required and blood return was not observed.The hemostatic valve did not break into two or more pieces and the hemostatic valve/brim cap/hub did not become detached from the sheath.Therefore, the awareness date for the reportable issue is (b)(6) 2021.The air flowing back into the side port issue was assessed as mdr reportable.There is potential for significant bleeding or air embolism that might require additional intervention to prevent serious injury or death.The no temperature issue was assessed as not mdr reportable.The ablation cannot be performed since there is no radiofrequency (rf) energy applied.The most likely consequence is an intraprocedural delay.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event, is remote.The carto recognition issue was assessed as not mdr reportable.The device cannot be recognized by the carto system, the user will not be able to use the device and will have to replace it.The most likely consequence is an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death is remote.

Manufacturer Narrative

The device evaluation was completed on 6/22/2021.It was reported that a patient underwent an ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ small and an issue with air flowing back into the side port occurred.Initially, it was reported that when the thermocool® smart touch® sf bi-directional navigation catheter (stsf lot 30479620m) was connected to the carto 3 system, temperature was not displayed.The catheter was replaced with another stsf (lot #30479663m) and it was not recognized on the carto 3.The catheter was replaced, and the issue was resolved.It was also reported that after the sheath was inserted, error lined from sample port.The sheath was replaced and the issue was resolved.The procedure was completed without patient consequence.On 4/25/2021, additional information was received clarifying that after the sheath was inserted, bubble was introduced from the side port.It was not reported that air entered the patient¿s body.Percutaneous or surgical removal were not required and blood return was not observed.The hemostatic valve did not break into two or more pieces and the hemostatic valve/brim cap/hub did not become detached from the sheath.Device evaluation: visual analysis of the returned sample revealed that no damage or anomalies were observed on the vizigo sheath and the flow pump was tested and no issues were observed.No malfunctions were observed during the product analysis.A device history record (dhr) evaluation was performed for the finished device 00001502 number, and no internal action related to the complaint was found during the review.Based on the completed dhr, the h4.Device manufacture date has been populated with 11/5/2020.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No malfunction was observed during the product analysis.According to the odp (optimal performance guide), there are some precautions on inserting the dilator into the vizigo sheath: ¿always insert a dilator straight into the center of the sheath¿s valve to prevent damage to the valve.Do not insert a dilator at an angle, as damage to the sheath valve may occur.¿.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
• MDR Report Key: 11868794
• MDR Text Key: 266196964
• Report Number: 2029046-2021-00799
• 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: foreign
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2021
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THMCL SMTCH SF BID, TC, D-F; THMCL SMTCH SF BID, TC, D-F; UNKNOWN BRAND CATHETER; UNKNOWN BRAND SHEATH