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

Model Number 301803M

Device Problems Occlusion Within Device (1423); Material Perforation (2205); Physical Resistance (2578); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent a procedure with a preface sheath and a perforation of the sheath occurred.It was originally reported that during the procedure, the preface sheath malfunctioned.The procedure was completed successfully with a similar-like device.There was no patient consequence.Upon request, additional clarification was provided on the event on (b)(6) 2014.The preface sheath was obstructed near the tip.There was no physical damage to the preface sheath.The physician also experienced resistance with the sheath.The physician felt some resistance with the transseptal needle, in which there was perforation in the side of the sheath, without any contact with the patient.Therefore, the physician perceived the obstruction.The awareness date for this record is (b)(6) 2014 because additional information was received stating that there was a perforation of sheath which is indicative of a reportable event.

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 was reviewed.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).

• 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 3259 9; MX 32599
• Manufacturer (Section G): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 3259 9; MX 32599
• Manufacturer Contact: jaime chavez ; 9098398483
• MDR Report Key: 4290529
• MDR Text Key: 5085047
• Report Number: 9673241-2014-00542
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K982740
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/06/2014

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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/02/2014
• Initial Date FDA Received: 12/02/2014
• Was Device Evaluated by Manufacturer?: No
• 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