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 Tissue Damage (2104)

Event Date 04/30/2015

Event Type  malfunction  

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.Device history review - a review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.Review of lot 17172358 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a preface sheath and a perforation through the sheath occurred.After the first transeptal puncture, the preface sheath slipped back to the right atrium.Therefore a new puncture of the septum was needed.The transeptal needle was inserted into the sheath again, but no puncture was possible.The x-ray picture showed that there was a perforation of the sheath with the needle at the tip.The sheath and needle were pulled out easily and the puncture was done again with new products.The procedure was finished successfully.There was no patient consequence.This event is indicative of a reportable event because of the possibility of patient injury due to misalignment of the needle to the intended path.

Manufacturer Narrative

The bwi failure analysis lab received the device for evaluation on 07/28/2015.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 procedure with a preface sheath and a perforation through the sheath occurred.Upon receipt, the vessel dilator was visually inspected and the needle tip was observed outside of it.Preface sheath was not received.Then per the reported event, a scanning electron microscope (sem) analysis was performed and the results showed that the needle was the cause of the perforation.No other anomalies were observed that could have influenced the perforation.Additionally, a shape master comparison was performed and the vessel dilator was found within specifications.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 evidence demonstrated that the vessel dilator was within manufacturing specifications.

• 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: shahe garabedian ; 9098397362
• MDR Report Key: 4905474
• MDR Text Key: 22378427
• Report Number: 9673241-2015-00441
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 06/21/2015

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 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: 07/28/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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