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 Twisted/Bent (2981)

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

Event Date 12/01/2021

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial flutter left (l-afl) procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - medium and the biosense webster inc, (bwi) product analysis lab found that the hemostatic valve was missing inside the hub of the device.Initially, it was reported that after the vizigo¿ sheath was advanced into the coronary, the catheter was exchanged out for an ablation catheter.The caller reported that when trying to advance the ablation catheter into the vizigo¿ sheath, the distal tip of the sheath became "torqued and kinked," and they were unable to further advance the ablation catheter.The vizigo¿ sheath was replaced, and the issue resolved.The procedure continued.No adverse patient consequences were reported.The issue with the distal tip being twisted was assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The resistance with sheath issue was assessed as not mdr reportable.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or friction between devices is a known occurrence.If resistance is encountered, the system may be withdrawn as a unit.This is a common practice during procedures.Since the vast majority of ep procedures utilize multiple device exchanges, an increased potential for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.This event is being reported because the biosense webster inc, (bwi) product analysis lab received the device for evaluation and found that the hemostatic valve was missing.The dilator was not returned, and some bents were observed.This finding was assessed as mdr reportable.Therefore, the awareness date for this reportable lab finding is (b)(6) 2022.

Manufacturer Narrative

The biosense webster, inc.(bwi) product analysis lab received the device on (b)(6) 2022.The device evaluation was completed on (b)(6) 2022.Bwi then conducted a visual inspection of the returned device.Visual analysis of the returned carto vizigo¿ sheath sample revealed that the hemostatic valve was missing.The dilator was not returned, and some bents were observed.A functional test was performed, in accordance with bwi procedures.The vessel dilator from another vizigo¿ and an stsf catheter were introduced into the vizigo¿ sheath and some resistance was felt during the testing.A device history record review was performed for the finished device 00001725 number, and no internal actions related to the complaint were found during the review the issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.According to the odp (optimal performance guide), there are some precautions on inserting the dilator into the vizigo sheath: ¿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.(b)(4).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The biosense webster, inc.(bwi) product analysis lab received the device on (b)(6) 2022.The device evaluation was completed on (b)(6) 2022.Bwi then conducted a visual inspection of the returned device.Visual analysis of the returned carto vizigo¿ sheath sample revealed that the hemostatic valve was missing.The dilator was not returned, and some bents were observed.A functional test was performed, in accordance with bwi procedures.The vessel dilator from another vizigo¿ and an stsf catheter were introduced into the vizigo¿ sheath and some resistance was felt during the testing.A device history record review was performed for the finished device 00001725 number, and no internal actions related to the complaint were found during the review the issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.According to the odp (optimal performance guide), there are some precautions on inserting the dilator into the vizigo sheath: ¿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.(b)(4).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial flutter left (l-afl) procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - medium and the biosense webster inc, (bwi) product analysis lab found that the hemostatic valve was missing inside the hub of the device.Initially, it was reported that after the vizigo¿ sheath was advanced into the coronary, the catheter was exchanged out for an ablation catheter.The caller reported that when trying to advance the ablation catheter into the vizigo¿ sheath, the distal tip of the sheath became "torqued and kinked," and they were unable to further advance the ablation catheter.The vizigo¿ sheath was replaced, and the issue resolved.The procedure continued.No adverse patient consequences were reported.The issue with the distal tip being twisted was assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The resistance with sheath issue was assessed as not mdr reportable.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.This event is being reported because the biosense webster inc, (bwi) product analysis lab received the device for evaluation and found that the hemostatic valve was missing.The dilator was not returned, and some bents were observed.This finding was assessed as mdr reportable.Therefore, the awareness date for this reportable lab finding is (b)(6) 2022.

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13591144
• MDR Text Key: 286059141
• Report Number: 2029046-2022-00371
• Device Sequence Number: 1
• Product Code: DYB
• 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
• Report Date: 02/24/2022

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: 07/17/2022
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2022
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2021
• 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: 7FR DECAN,11P,F,2.4MMLE,282MM,; UNK BRAND CABLE; UNK BRAND CATHETER; UNK BRAND SHEATH; UNK_CARTO 3