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

Catalog Number D138502

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Blood Loss (2597)

Event Date 05/07/2019

Event Type  malfunction  

Manufacturer Narrative

On 5/24/2019, the biosense webster inc.(bwi) product analysis lab (pal) received the device for evaluation and found the brim cap broken with missing pieces.Additionally, the hemostatic valve and friction ring were missing.The additional findings of broken brim cap has been assessed as mdr reportable.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.On 5/14/2019, a manufacturing record evaluation was performed, and no internal actions were found during the review.Manufacture reference no: (b)(4).

Event Description

It was reported that a male patient underwent an atrial fibrillation (afib) ablation procedure on which a carto vizigo¿ 8.5f bi-directional guiding sheath was used, and hemostatic valve detachment occurred which resulted in blood leakage from the sheath.During the procedure, the hemostatic valve became detached from the vizigo sheath.While the catheter was in the body, there was minimum to no blood.However, after removing the catheter, there was blood leaking from the sheath.The vizigo sheath was replaced and the issue resolved.No medical intervention or surgical intervention was performed and extended hospitalization was not required.Patient¿s outcome was fully recovered with no residual effects.Physician¿s opinion regarding the cause of the bleeding event is that it was related to a bwi product malfunction.The observed blood loss has been assessed as not mdr reportable.The observed hemostatic valve separation has been assessed as an mdr reportable malfunction.

Manufacturer Narrative

It was reported that a male patient underwent an atrial fibrillation (afib) ablation procedure on which a carto vizigo¿ 8.5f bi-directional guiding sheath was used, and hemostatic valve detachment occurred which resulted in blood leakage from the sheath.The investigational analysis completed (b)(6)2019.The device was inspected, and the brim cap was found broken and some pieces were missing.The hemostatic valve and the friction ring were missing.A manufacturing record evaluation was performed, and no internal actions were identified.The customer complaint was confirmed.The root cause of the damage on brim cap cannot be determined.However, an internal corrective action was created to investigate this issue.Manufacture ref no:(b)(4).

• Brand Name: CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8655703
• MDR Text Key: 149000442
• Report Number: 2029046-2019-03186
• Device Sequence Number: 1
• Product Code: LPB
• 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
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2019
• Device Catalogue Number: D138502
• Device Lot Number: 00001065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 05/30/2019
• Supplement Dates Manufacturer Received: 06/25/2019
• Supplement Dates FDA Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1