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

Model Number 301803M

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 08/22/2014

Event Type  malfunction  

Event Description

It was reported that a patient, underwent an atrial fibrillation procedure with a preface sheath which was irrigating inadequately as flow could not go through the sheath.There was no patient consequence.Per 21 cfr, part 803, this complaint is reportable.

Manufacturer Narrative

A) the bwi failure analysis lab received the device for evaluation.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) manufacturer's reference # (b)(4), is related to the same event.C) manufacturer's reference #: (b)(4).

Manufacturer Narrative

Evaluation summary.(b)(4) it was reported that a patient, underwent an atrial fibrillation procedure with a preface sheath which was irrigating inadequately as flow could not go through the sheath.The bwi failure analysis lab received the device for evaluation.Upon receipt, the preface sheath was visually inspected and it was found in normal conditions.Then per the reported event, a dimensional testing was performed and the preface sheath was found within specifications.Finally a lab sample smart touch was introduced through the sheath introducer, an irrigation test was then performed and no occlusions were observed.Water was flowing normally 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 cannot be confirmed.

• Brand Name: PREFACE® GUIDING SHEATH WITH MULTIPURPOSE CURVE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4118639
• MDR Text Key: 4920173
• Report Number: 2029046-2014-00324
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982740
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2014

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/22/2014
• Initial Date FDA Received: 09/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1