MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE; INTRODUCER, CATHETER

Model Number 301803M

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2019

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation.The device was returned in the condition reported as the tip of the dilator appears to be bent creating a small hole.In addition, only the dilator was returned.This returned condition remains a reportable issue.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.Still pending is the manufactured date.Therefore, a supplemental report will be submitted.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with two preface® guiding sheath with multipurpose curve and during use, both the sheaths were perforated.It was reported that the merit medical heartspan transseptal needle perforated the tip of the dilator.The preface® guiding sheath with multipurpose curve was replaced and the issue re-occurred with the second preface® guiding sheath with multipurpose curve.The issue was resolved when he needle was replaced.There was no difficulty while maneuvering the devices or during the withdrawals.The procedure continued.There was no patient consequence reported.The perforations on each of the sheaths were assessed as reportable issues.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent an atrial fibrillation (afib) procedure with two preface® guiding sheath with multipurpose curve.It was reported that the merit medical heartspan transseptal needle perforated the tip of the dilator.The preface® guiding sheath with multipurpose curve was replaced and the issue re-occurred with the second preface® guiding sheath with multipurpose curve.The issue was resolved when he needle was replaced.There was no difficulty while maneuvering the devices or during the withdrawals.The procedure continued.There was no patient consequence reported.The returned device was visually inspected and the mentioned needle was not returned for analysis.A perforated condition was observed located at 1 cm from the distal tip where the tip with the sheath fusion occurred.No other anomalies or damages were observed on the inspected part.The unit was placed under a vision system in order to obtain a magnified image of the puncture observed at the vessel dilator sheath.The edges of the punctured section presented evidence of elongations and frayed edges caused by unknown mechanical device.The path observed on the elongations indicates that the direction of the damage was from the inside of vessel dilator to the outside.These characteristics suggest that the device was induced to a cutting tension with a sharp mechanical device from the interior of the body with direction to the outside that exceeded the material yield strength prior to the puncture.No other issues were noted during the microscopic analysis.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.During manufacturing process, all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of damage from leaving the facility.The customer complaint was confirmed.The root cause of puncture 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 ref.No: (b)(4).

• Brand Name: PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9359806
• MDR Text Key: 195389042
• Report Number: 2029046-2019-03921
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10846835000047
• UDI-Public: 10846835000047
• Combination Product (y/n): N
• PMA/PMN Number: K982740
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

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: 06/30/2022
• Device Model Number: 301803M
• Device Catalogue Number: 301803M
• Device Lot Number: 17880752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 02/18/2020
• Supplement Dates FDA Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NON BWI-MERIT MEDICAL HEARTSPAN TRANSSEPTAL NEEDLE; PREF.GUIDING SHEATH W/MULT.CRV