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

Model Number 301803M

Device Problems Occlusion Within Device (1423); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/29/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a preface® guiding sheath with multipurpose curve and an occlusion occurred preventing to flush it.During procedure, the pump displayed an occlusion warning.When the thermocool® smart touch¿ electrophysiology catheter was inserted, it occluded the sheath preventing to flush.This occurred inside the patient.In addition, an error 106 and 279 were displayed.The procedure was completed by exchanging catheter and sheath.There was no patient consequence.This complaint is being reported due to the potential risk to the patient.

Manufacturer Narrative

Concomitant bwi product: product: thermocool® smart touch¿ electrophysiology catheter, us catalog # d133601, lot # 17024440m.(b)(4).The bwi failure analysis lab received the device for evaluation.Upon receipt, the preface sheath (sheath introducer) was visually inspected and was found in normal conditions.Vessel dilator was also returned and was found in good conditions as well.Per the reported event, a microscopic visual inspection was performed over the two devices and no damages were observed.Afterwards, a dimensional testing was performed over the vessel dilator and sheath introducer and both were within specifications.In addition, the vessel dilator was introduced through the sheath introducer and no resistance/friction was experienced.Finally a lab sample smart touch was introduced through the sheath introducer and no friction was found either.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 was not confirmed.Management is notified of failure analysis results using monthly complaint trend reporting.No significant trends have been identified at this time; therefore no capa activity is required.

• 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: 4340670
• MDR Text Key: 5140460
• Report Number: 2029046-2014-00481
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: 08/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• 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: 10/01/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2014
• 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