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

Model Number D138502

Device Problems Material Perforation (2205); Obstruction of Flow (2423)

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

Event Date 12/14/2021

Event Type  malfunction  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a carto vizigo¿8.5f bi-directional guiding sheath ¿ medium and a perforation on sheath issue occurred.It was reported that after the transseptal puncture, the vizigo¿ sheath lumen appeared wider than before the transseptal puncture.The physician believed that the transseptal needle may have made the lumen larger.As a result, the pentaray catheter could not be advanced through the end of the vizigo¿ sheath.The sheath was exchanged with another vizigo¿ sheath to continue.No adverse patient consequence was reported.Additional information was received on 17-dec-2021.The resistance they were having with the sheath was when they were trying to put the catheter into the sheath.There was physical damage on sheath/dilator as the tip was observed to be damaged.It is unknown if there was any occlusion when irrigating the sheath.The catheter/needle was not able to be moved through the sheath.They were inserting the catheter into the sheath.Additional information was received on 20-dec-2021 with further details provided about the damage that was reported on (b)(6) 2021.The damage that was observed was believed to be from the transseptal needle.It was not buckled or rolled up on itself.It was not splayed.It is unknown how far from the distal tip the damage was found.It is unknown if any internal sheath mechanism was exposed.It is unknown if the tip was rough or non-slippery.It is unknown if there were any lifted or damaged electrode.It is unknown if the damage was seen on any other section of the sheath (i.E., valve, hub, luer hub, etc).Additional information was received on 28-dec-2021.The reporter cannot confirm if the sheath was perforated by the transeptal needle but believes it possibly was.Difficulty was experienced while maneuvering the catheter (could not advance).

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 number: (b)(4).

Manufacturer Narrative

The device evaluation was completed on 07-feb-2022.It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a carto vizigo¿8.5f bi-directional guiding sheath ¿ medium and a perforation on sheath issue occurred.It was reported that after the transseptal puncture, the vizigo¿ sheath lumen appeared wider than before the transseptal puncture.The physician believed that the transseptal needle may have made the lumen larger.As a result, the pentaray catheter could not be advanced through the end of the vizigo¿ sheath.The sheath was exchanged with another vizigo¿ sheath to continue.No adverse patient consequence was reported.The resistance they were having with the sheath was when they were trying to put the catheter into the sheath.There was physical damage on sheath/dilator as the tip was observed to be damaged.It is unknown if there was any occlusion when irrigating the sheath.The catheter/needle was not able to be moved through the sheath.They were inserting the catheter into the sheath.The damage that was observed was believed to be from the transseptal needle.It was not buckled or rolled up on itself.It was not slayed.It is unknown how far from the distal tip the damage was found.It is unknown if any internal sheath mechanism was exposed.It is unknown if the tip was rough or non-slippery.It is unknown if there were any lifted or damaged electrode.It is unknown if the damage was seen on any other section of the sheath (i.E., valve, hub, luer hub, etc).Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation.Bwi then conducted a visual inspection and functional evaluation of the returned device.Visual analysis of the returned sample revealed that the irrigation hole was damaged, elongation was observed in the hole diameter.However, no perforation was observed in the sheath.The original dilator was not received.In addition, a bent was observed on the carto vizigo¿ shaft.A functional test was performed, in accordance with bwi procedures.The vessel dilator was not returned, and another dilator was used, and a stsf catheter was introduced into the vizigo¿ sheath and some resistance was felt in the bents found.A device history record (dhr) evaluation was performed for the finished device [50000036] number, and no internal actions related to the reported complaint condition were identified.Based on the dhr, the h4.Device manufacture date has been updated.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the reported perforation on sheath.Investigation findings: mechanical problem identified (c07)/ investigation conclusions: cause not established (d15) / component code: tip (g04129) and rod/shaft (g04112) were selected as related to the damage observed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13212692
• MDR Text Key: 289668391
• Report Number: 2029046-2022-00065
• 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,Followup,Followup
• Report Date: 03/04/2022

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: 10/13/2022
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 50000036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 01/10/2022
• Supplement Dates Manufacturer Received: 01/13/2022; 02/07/2022
• Supplement Dates FDA Received: 02/07/2022; 03/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2021
• 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: PENTARAY NAV ECO 7FR, D, 2-6-2; UNK TRANSSEPTAL NEEDLE; UNKNOWN BRAND CABLE; UNK_CARTO VIZIGO SHEATH