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

Model Number 301803MS

Device Problem Occlusion Within Device (1423)

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

Event Date 12/10/2014

Event Type  malfunction  

Event Description

It was reported that during an atrial fibrillation ablation procedure using a preface® guiding sheath, the sheath became occluded.The occlusion occurred during the procedure once the sheath and catheter were advanced across the septum, making this event reportable due to the risk to patient.No adverse patient consequences were reported.The devices have not yet been returned to bwi for analysis.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Concomitant products: smarttouch catheter, lot# unk.(b)(4).The product investigation is pending product return.

Manufacturer Narrative

Bwi has received the complaint device for evaluation.A supplemental report of the analysis findings will be submitted once the investigation is completed.(b)(4).

Manufacturer Narrative

(b)(4) it was reported that during an atrial fibrillation ablation procedure using a preface guiding sheath, the sheath became occluded.The occlusion occurred during the procedure once the sheath and catheter were advanced across the septum, making this event reportable due to the risk to patient.Upon receipt, the preface sheath (sheath introducer) was visually inspected and it was found in normal conditions.The vessel dilator was also returned and it was found in good conditions as well.Then 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, an irrigation test was then performed and no occlusions were observed.Water was flowing normally the customer complaint cannot be confirmed.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.

• Brand Name: PREFACE® GUIDING SHEATH WITH MULTIPURPOSE-SHORT 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: 4393229
• MDR Text Key: 5362021
• Report Number: 9673241-2015-00012
• 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,Followup
• Report Date: 12/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 301803MS
• Device Catalogue Number: 301803MS
• Device Lot Number: OEM_301803MS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1