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

Model Number 301803M

Device Problem Material Perforation (2205)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/23/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation still in progress.A supplemental report or device evaluation will be submitted.Concomitant product: 2 distributed - transeptal needles, model #: d-1299-03-s, lot #: unknown.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with three preface sheaths.The transseptal needle perforated the dilator and the preface sheath.This preface sheath was replaced and the issue reoccurred with the second preface sheath.The procedure was completed with no patient consequences.It was also reported that during insertion of the transseptal needle into a third preface sheath, resistance was felt.The issue of the transseptal needle perforating the dilator and the preface sheath was assessed as a reportable malfunction as there was potential for cardiac/vascular injury due to misalignment of the needle to the intended path.The issue of resistance was felt was assessed as not reportable as the potential for patient injury was remote.Clarification was requested for the specific issue for each preface sheath.However, no additional clarification has been received.Therefore, we will conservatively report this event under all three preface sheaths.

Manufacturer Narrative

The manufactured date and expiration date have been provided.Therefore, expiration date and manufactured date have been populated.(b)(4).

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.The device history record (dhr) for the lot number 17551656 has been reviewed and it was verified that device was manufactured in accordance with documented specifications and procedures.(b)(4).

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 12/8/2016.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.(b)(4).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with three preface sheaths.The transseptal needle perforated the dilator and the preface sheath.This preface sheath was replaced and the issue reoccurred with the second preface sheath.The procedure was completed with no patient consequences.It was also reported that during insertion of the transseptal needle into a third preface sheath, resistance was felt.The returned device was visually inspected and a pin hole was observed in the sheath introducer and the vessel dilator.Per the event reported, functional test was performed; vessel dilator and sheath introducer were compared against the shape master and were found within the tolerance zone specified.In addition, a microscopic analysis was performed and the there was evidence that the punctures could be caused by the transseptal needle insertion.Finally, a catheter was introduced through the sheath introducer and no resistance was felt during the insertion.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.The customer complaint has been verified.However, the root cause of the punctures could be caused during the transseptal needle insertion.However, neither the analysis nor the dhr suggest that the failure reported could not be related to the manufacturing process.

• Brand Name: PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 6044556
• MDR Text Key: 58403219
• Report Number: 9673241-2016-00716
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K982740
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/26/2016

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: 07/31/2019
• Device Model Number: 301803M
• Device Catalogue Number: 301803M
• Device Lot Number: OEM_301803M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/23/2016
• Initial Date FDA Received: 10/20/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 11/14/2016; 11/16/2016; 12/13/2016; 01/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2016
• 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