MAUDE Adverse Event Report: BIOSENSE WEBSTER INC 8.5F SHEATH WITH CURVE VIZ MDC; INTRODUCER, CATHETER

Catalog Number D138502

Device Problems Backflow (1064); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2019

Event Type  malfunction  

Manufacturer Narrative

The biosense webster inc.(bwi) product analysis lab (pal) received the device for evaluation and found the brim cap cracked, a missing piece with the hemostatic valve attached, and the sheath bent in two places approximately 14.3 cm and 56.5 cm from the distal end.These finding coincide with what was reported.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 5/2/2019, a manufacturing record evaluation was performed for the finished device and no internal actions were identified.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a carto vizigo¿ 8.5f bi-directional guiding sheath and a brim cap detached allowing air in the sheath hub.Initially, it was reported that the vizigo sheath had bubbles trapped in the hub.When trying to clear the bubbles, the orange ring at the base of the hub cracked.Sheath replacement resolved the issue.No patient consequences were reported.The detached brim cap and air in sheath hub has been assessed as mdr reportable as device integrity was compromised.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for atrial fibrillation with a carto vizigo¿ 8.5f bi-directional guiding sheath and a brim cap detached allowing air in the sheath hub.The investigational analysis completed 6/26/2019.The device was inspected and the brim cap was observed cracked with a piece missing.The hemostatic valve was observed with no damage and the sheath was observed bent.The device was connected to the cool flow pump and the device was irrigating correctly.No bubbles or alarms were observed during the test.A manufacturing record evaluation was performed and no internal actions were identified.The customer complaint was confirmed.The root cause of the damage on the brim cap cannot be determined.However, an internal corrective action was created for further investigation.The root cause of the bents could be related to the handling of the device.Manufacture reference no: (b)(4).

• Brand Name: 8.5F SHEATH WITH CURVE VIZ MDC
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRVINE); 33 technology drive; irivine CA 92618
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8604346
• MDR Text Key: 145966419
• Report Number: 2029046-2019-03128
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/26/2019
• Device Catalogue Number: D138502
• Device Lot Number: 00001063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2018
• 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