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

Model Number D138502

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Air Embolism (1697); ST Segment Elevation (2059); No Code Available (3191)

Event Date 06/17/2020

Event Type  Injury  

Manufacturer Narrative

"since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Mre review: a manufacturing record evaluation was performed for the finished device 00001235 number, and no non-conformances related to the complaint was found during the review.(b)(4).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 a male patient underwent atrial fibrillation (afib) ablation procedure with carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and suffered air embolism and st-segment elevations requiring coronary angiography.It was reported that during afib case the patient received an air embolism through the vizigo sheath which was followed by a blood pressure drop and st-segment elevation.A coronary angiogram was performed and no air embolism was observed in the coronary arteries.The st elevation and blood pressure returned to normal.100% oxygen was given.The procedure was subsequently completed.The patient will be returned to coronary care unit (ccu) for observation.The event occurred during use of biosense webster product.In the opinion of the physician the cause of the patient event was procedure and staff error.The patient had fully recovered after 1 extra day of observation for any residual/neurological side effects.The sheath was not connected to the smartablate pump.

Manufacturer Narrative

During an internal review on july 10, 2020, corrections were noted to the 3500a initial report.B2.Is life threatening, b 4.Lot needed to be populated.Therefore, checked b 2.Is life threatening and added the lot number to the b 4.Lot.H3.Reason for non- evaluation from ¿device evaluation anticipated, but not yet begun¿ to ¿other¿.H6.Method codes from ¿type of investigation not yet determined¿ to ¿device not returned¿ and ¿analysis of production records¿.H6.Result codes from ¿results pending completion of investigation¿ to ¿no finding available¿.H6.Conclusion codes from ¿conclusion not yet available¿ to ¿cause not established¿.The bwi product analysis lab received the device for evaluation on july 22, 2020.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 (b)(6)2020 , the product investigation was completed.It was reported that a male patient underwent atrial fibrillation (afib) ablation procedure with carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium and suffered air embolism and st-segment elevations requiring coronary angiography.It was reported that during afib case the patient received an air embolism through the vizigo sheath which was followed by a blood pressure drop and st-segment elevation.A coronary angiogram was performed and no air embolism was observed in the coronary arteries.The st elevation and blood pressure returned to normal.100% oxygen was given.The procedure was subsequently completed.The patient will be returned to coronary care unit (ccu) for observation.Device evaluation details: the device was visually inspected, and it was found kink in sheath.Deflection test was performed, and it was found within specifications, the device was deflecting correctly.Then, electrical test was performed and the device failed, no electrical readings were observed on electrode #03.Then, a cool flow pump test was performed and it was found within specifications, the device was irrigating correctly, no irrigation issues were observed.Then, the device was connected to carto and the catheter was not visualized and no errors were observed.A failure analysis was performed and the device was dissected on the tip area, it was determined that the root cause was an internal failure from the cut to the electrode.A manufacturing record evaluation was performed and no internal action related to the complaint was found during the review.The root cause of the adverse event remains unknown.The root cause of the kink on sheath and wires broken observed on the connector cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures, it could be related to the use 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 reference number: pc-000715207.

• Brand Name: CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH MEDIUM
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 10260923
• MDR Text Key: 199266335
• Report Number: 2029046-2020-00846
• 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,Followup
• Report Date: 06/17/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2020
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 07/10/2020; 08/12/2020
• Supplement Dates FDA Received: 08/05/2020; 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; SOUNDSTAR ECO GE 8F CATHETER; UNKNOWN BRAND CATHETER CABLE; UNK_SMARTABLATE PUMP
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention