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

Model Number D138502

Device Problems Device-Device Incompatibility (2919); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2022

Event Type  malfunction  

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 ¿ medium for which biosense webster¿s product analysis lab identified the hemostatic valve to be separated.It was initially reported by the customer that the inner sheath couldn¿t advance in the outer sheath due to the impediment.The second sheath was used to complete the operation.There was no report of adverse event on patient as the issue occurred prior to the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ medium being used on the patient.Additional information received indicated the physician believed there was a physical distortion on the dilator and the sheath was ¿too tight¿.No damage was noted on the tip.The inner sheath could not normally advance to the specified depth, and the force was added at end of the device, but it still could not reach the normal depth.When the force acted on the end of the sheath, it was twisted to a certain extent.The sheath was not occluded when irritating and it was not completely blocked; the dilator could still be moved through and did not get stuck.The device did not break into two or more pieces, no internal components were exposed.No sharp rings.No damage to the hemostatic valve the customer¿s reported issues of resistance with the sheath and dilator damage are not mdr reportable issues since the potential these it could cause or contribute to a death or serious injury, or other significant adverse event, are remote.On 8-jul-2022, the bwi pal revealed that a visual inspection of the returned device found the hemostatic valve dislodged inside the hub component.This finding was reviewed and determined to be an mdr reportable malfunction.

Manufacturer Narrative

Device evaluation details: the device was returned to biosense webster (bwi) for evaluation and the evaluation has been completed.Visual inspection and microscopic examination of the returned device were performed following bwi procedures.Visual analysis revealed that the hemostatic valve was dislodged inside of the hub component.No other damages or anomalies were observed on the sheath or the dilator.A microscopic examination of the hemostatic valve surface showed stress marks on the outer diameter.The damage observed could be related to the incorrect insertion of the dilator into the sheath causing the dislodgment of the valve; the stress marks and physical damage observed suggest that excessive force or manipulation was applied; however, this could not be conclusively determined.The dilator and a good-known laboratory sample catheter were introduced through the sheath, and no obstruction or resistance was detected.The dilator's outer diameter was measured, and dimensions were found within specifications.Additionally, the customer provided picture of the complaint device to aid in the investigation.A picture showing the catheter leaking water was received for analysis, the photo does not provide sufficient information related to the reported event and therefore no result can be obtained from it a device history record was performed for the finished device batch number, and no non-conformances were identified.The issue was confirmed since the hemostatic valve failure could cause the resistance/obstruction reported by the customer.The odp (optimal device performance guide) contains the following caution: always insert a dilator straight into the center of the sheath¿s valve to prevent damage to the valve.Do not insert a dilator at an angle, as damage to the sheath valve may occur.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Initial reporter phone: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ MEDIUM
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRVINE); 33 technology drive; irvine CA 92618
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15136805
• MDR Text Key: 304135740
• Report Number: 2029046-2022-01752
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/30/2022

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: 11/06/2022
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 50000051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2022
• Initial Date Manufacturer Received: 07/08/2022
• Initial Date FDA Received: 07/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2021
• 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
• Treatment: 8.5F SHEATH WITH CURVE VIZ MDC