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

Model Number 301803M

Device Problems Partial Blockage (1065); Flushing Problem (1252); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent a procedure with a preface sheath and the sheath had inadequate irrigation.It was reported that there was occlusion of saline in the preface sheath because the smart touch unidirectional catheter was blocking the lumen.The catheter and sheath were exchanged and this resolved the issue.The procedure was completed without patient consequence.Upon request, additional information was provided on the event.The issue was noticed not immediately but some time into the procedure.The smart touch unidirectional catheter was inserted through the preface sheath while inside the patient.The occlusion was enough to bring out an occlusion alarm from the irrigation pump.A regular infusion pump was used, not the coolflow pump.The problem occurs when the smart touch unidirectional catheter completely occludes the sheath and prevents the flush.The issue was resolved with exchanging the catheter and the sheath.Since they were unable to continuously flush with the preface sheath during the procedure, this event is indicative of a reportable event.

Manufacturer Narrative

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.Concomitant product: smart touch unidirectional catheter, model #: d-1336-01-s, lot #: 17024440m.(b)(4).

Manufacturer Narrative

(b)(4) it was reported that a patient underwent a procedure with a preface sheath and the sheath had inadequate irrigation.It was reported that there was occlusion of saline in the preface sheath because the smart touch unidirectional catheter was blocking the lumen.The catheter and sheath were exchanged and this resolved the issue.The procedure was completed without patient consequence.Upon request, additional information was provided on the event.The issue was noticed not immediately but some time into the procedure.The smart touch unidirectional catheter was inserted through the preface sheath while inside the patient.The occlusion was enough to bring out an occlusion alarm from the irrigation pump.A regular infusion pump was used, not the coolflow pump.The problem occurs when the smart touch unidirectional catheter completely occludes the sheath and prevents the flush.The issue was resolved with exchanging the catheter and the sheath.Upon receipt, the preface sheath (sheath introducer) was visually inspected and it was found in normal conditions.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 device history record (dhr) could not be reviewed since the lot number was not reported.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. (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 ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4253115
• MDR Text Key: 5012635
• Report Number: 9673241-2014-00491
• 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,Followup
• Report Date: 08/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2014
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/26/2014
• 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