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

Model Number D138501

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2019

Event Type  malfunction  

Manufacturer Narrative

Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a 8.5f sheath with curve viz mdc, and a hemostatic valve separation issue occurred.During the procedure, the valve broke off the sheath.Sheath replacement resolved the issue.The carto 3 system was operating per specifications and was not responsible for the product issue.The sheath was not determined to be the root cause of the complaint reported.The procedure was continued.No adverse patient consequences were reported.The observed hemostatic valve separation issue has been assessed as an mdr reportable malfunction.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a 8.5f sheath with curve viz mdc, and a hemostatic valve separation issue occurred.The biosense webster inc.(bwi) product analysis lab (pal) received the device for evaluation.Upon initial inspection, the bwi pal observed the brim cap separated from the hub.The hub did not appear broken and snaps back in place.These findings coincide with what was initially reported.The observed hemostatic valve separation 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.Manufacture reference no: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for atrial fibrillation (afib) with a 8.5f sheath with curve viz mdc, and a hemostatic valve separation issue occurred.During the procedure, the valve broke off the sheath.The investigational analysis completed 4/29/2020.The device was inspected.The brim cap, hemostatic valve, and friction ring were observed separated from the hub.No cracks or damages were observed on the brim cap.However, glue residues were noticed.A manufacturing record evaluation was performed, and no internal actions were identified.The customer complaint was confirmed.The root cause of the brim cap detachment and damage on the hemostatic valve could be related to handling of the device during the procedure.However, this cannot be conclusively determined.Manufacture reference no: (b)(4).

• Brand Name: 8.5F SHEATH WITH CURVE VIZ SMC
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9565247
• MDR Text Key: 199279900
• Report Number: 2029046-2020-00034
• Device Sequence Number: 1
• Product Code: LPB
• 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: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2020
• Device Model Number: D138501
• Device Catalogue Number: D138501
• Device Lot Number: 00001120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Date Manufacturer Received: 04/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM