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

Model Number D138503

Device Problem Backflow (1064)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

The biosense webster, inc.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 # (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large and an event of ¿air flows back into the side port¿ occurred.It was initially reported that during the procedure, a bubble was visible during aspiration, in the hub of the vizigo sheath.The physician flushed the sheath and continued to aspirate.The procedure was completed without patient consequence.The issue was discovered while the product was being used on the patient.Blood return was not observed, and air did not enter the patient¿s body.No surgical or percutaneous removal was required.The air in the side port tubing was assessed as a reportable malfunction.On january 2, 2020, the biosense webster, inc.Product analysis lab received the device for evaluation.The initial visual inspection of the product revealed that the brim cap looks intact and will not separate from hub, the dilator was missing, and there was a kink in the shaft, approximately 18 inches from the tip.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large and an event of ¿air flows back into the side port¿ occurred.It was initially reported that during the procedure, a bubble was visible during aspiration, in the hub of the vizigo sheath.The physician flushed the sheath and continued to aspirate.The device was visually inspected, and the shaft was found kinked, everything else appeared in normal condition.The device was then tested with the cool flow pump and passed, as no bubbles or alarms were observed.Also, there was no water leakage was observed from hemostatic valve.A manufacturing record evaluation was performed for the finished device 00001127 number, and no internal actions related to the complaint was found during the review.The customer complaint was not confirmed.Manufacturer's reference # (b)(4).

• Brand Name: CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ LARGE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9541091
• MDR Text Key: 199271903
• Report Number: 2029046-2020-00002
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835016260
• UDI-Public: 10846835016260
• 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: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2020
• Device Model Number: D138503
• Device Catalogue Number: D138503
• Device Lot Number: 00001127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1