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

Model Number D138503

Device Problem Device-Device Incompatibility (2919)

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

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).As stated in the complaint form, the event date is unknown.The bwi product analysis lab received the device for evaluation (b)(6)2022.The device evaluation was completed on (b)(6)2022.The product was returned to biosense webster for evaluation.Visual analysis of the returned sample revealed that the hemostatic valve was found dislodged inside the hub of the vizigo sheath.A dilator was introduced with the hemostatic valve dislodged, and resistance was found.Then the hemostatic valve was taken off the hub, the dilator was introduced again, and no resistance was found.A microscopic examination of the hemostatic valve surface showed evidence of damage to the outer diameter.The dilator outer diameter was measured, and dimensions were found within specifications.The hemostatic valve dislodged could be related to the resistance reported by the customer.A device history record was performed, and no internal actions related to the reported complaint were identified.The issue reported by the customer was confirmed.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.This product issue will be addressed through bwi's quality system.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - large and the biosense webster inc.Product analysis lab observed a hemostatic valve separation issue.Initially it was reported that the dilatator of the vizigo sheath was not insertable.The event occurred during sterile processing.The event occurred during field inspection.No patient consequence was reported.Additional clarification was requested and the response was received.The dilator was not insertable due to resistance.No physical damage on the sheath or dilator.There was no occlusion when irrigating the sheath.The sheath was narrowed.It was not possible to move the dilator inside the sheath.The event was assessed as not mdr reportable for a resistance with sheath issue.Interference or friction between devices is a known occurrence.If resistance is encountered, the system may be withdrawn as a unit.This is a common practice during procedures.Since the vast majority of ep procedures utilize multiple device exchanges, an increased potential for patient injury is remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6)2022 the hemostatic valve was found dislodged inside the hub of the carto vizigo¿ 8.5f bi-directional guiding sheath ¿ large.The returned condition was assessed as mdr reportable for a hemostatic valve separation issue.The awareness date for this reportable lab finding was (b)(6)2022.

• Brand Name: CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ LARGE
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15697455
• MDR Text Key: 304819668
• Report Number: 2029046-2022-02688
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016260
• UDI-Public: 10846835016260
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K170997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/30/2022

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: 04/11/2023
• Device Model Number: D138503
• Device Catalogue Number: D138503
• Device Lot Number: 00001965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2022
• Initial Date FDA Received: 10/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2022
• 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