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

Model Number D138502

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: an analysis was performed on the pictures that were provided by the customer.According to the pictures, the tip was observed rolled in and one irrigation hole was observed distended.The customer complaint was confirmed.The product analysis was performed as appropriate in order to find the root cause of the complaint.The device was visually inspected and it was found kinked.The dilator was introduced and resistance/friction was not felt when it was advanced through the sheath.At the end of the sheath, it was found that the introducer came out of the side hole of the sheath due to the excessive damaged tip.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The customer complaint was confirmed.The root cause of the kink and that the introducer came out of one of the side holes of the sheath cannot be related to the manufacturing process since there is evidence that the device was manufactured in accordance with documented specification and procedures.It could be related to the handling of the device during the procedure; however, this cannot be conclusively determined.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 an atrial fibrillation (afib) procedure with a carto vizigo¿ 8.5f bi-directional guiding sheath - medium, and the guidewire went through the irrigation hole.Initially it was reported that at the end of the procedure it was noticed that the introducer came out of one of the side holes of the sheath.The sheath worked fine during the procedure and it was noticed that the introducer had gone through the side hole at the end when the physician was analyzing the sheath.The introducer was first advanced at the beginning of the case but the change in the side hole was noticed at the end of the procedure.There was no report of patient consequence.There were no issues with the hemostatic valve and nothing became unattached.There was good blood return.No air was entered into the body.No surgical intervention was required.No patient consequence was reported.Introducer going through the irrigation hole instead of the lumen 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, was remote.The biosense webster, inc.Product analysis lab received the device for evaluation on march 17, 2020 and identified that the distal tip of the shaft appeared kinked/folded.This returned condition was assessed as not mdr reportable.The device integrity was maintained and no internal components were exposed to the patient.The most likely consequence was an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.Additional information was received on april 23, 2020 on the event.At the end of the procedure, the physician decided to swap the carto vizigo¿ 8.5f bi-directional guiding sheath - medium for a shorter sheath.It is this physician's practice to insert the dilator for retraction to make the sheath more stiff.They retracted the sheath to the right side, inserted a guidewire and then the dilator over the wire.At the end of the insertion, the physician felt some resistance but since the sheath was straight, continued to retract.When they got the sheath out, they saw that the dilator went out through the irrigation hole.There was no patient consequence.They haven't seen this before nor since.It is believed that the guidewire went through the hole.This event was originally considered non-reportable, however, bwi became aware of the guidewire going through the irrigation hole instead of the lumen on april 23, 2020 and have reassessed the event as reportable.Therefore, the awareness date for this record is april 23, 2020.

Manufacturer Narrative

During additional assessment, it was determined on (b)(6)2020 that the most probable outcome of this failure mode is a procedure delay.Therefore, there was no risk to the patient.This event was reassessed from mdr reportable to not mdr reportable.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; 33 technology drive; irvine CA 92618
• MDR Report Key: 10076532
• MDR Text Key: 195580080
• Report Number: 2029046-2020-00614
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835016277
• UDI-Public: 10846835016277
• 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
• Report Date: 03/02/2020

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: 12/10/2020
• Device Model Number: D138502
• Device Catalogue Number: D138502
• Device Lot Number: 00001237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Initial Date Manufacturer Received: 04/23/2020
• Initial Date FDA Received: 05/20/2020
• Supplement Dates Manufacturer Received: 08/14/2020
• Supplement Dates FDA Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND SHEATH.