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

Model Number 301803M

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2014

Event Type  malfunction  

Event Description

It was reported that a patient, underwent a procedure with a preface® guiding sheath with multipurpose curve and a perforation on dilator device malfunction occurred.At the moment of the needle passage, this one crossed the dilator.There was no patient consequence.The procedure was completed successfully with a similar-like device.As per the information reported, the needle is not directed in the intended direction and this may lead to be a potential risk for the patient.Therefore, this complaint is reportable.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Manufacturer Narrative

Multiple attempts have been made to request for the complaint product to be returned for analysis.Product was not returned for investigation as initially reported.As the lot # 17021493 was provided, the device history records 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.(b)(4).

Manufacturer Narrative

A) the bwi failure analysis lab received the device for evaluation on november 2, 2014.The analysis has begun but is not completed at this time.B) manufacturer's reference # (b)(4).

Manufacturer Narrative

Manufacturer's ref.No: (b)(4) it was reported that a patient, underwent a procedure with a preface® guiding sheath with multipurpose curve and a perforation on dilator device malfunction occurred.At the moment of the needle passage, this one crossed the dilator.There was no patient consequence.The procedure was completed successfully with a similar-like device.As per the information reported, the needle is not directed in the intended direction and this may lead to be a potential risk for the patient.The preface sheath and vessel dilator were returned for analysis.The needle used was not returned by the customer.Both were visually inspected and a puncture was found at 1.2 cm from distal tip end.Then per the reported event, the vessel dilator was compared with the shape master and it was within the limits.In addition, a sem test was carried out over the damaged section and the results showed evidence of elongations and scratches.Internal surface of the vessel dilator did not show evidence of damages that could be related to the perforation.Damages observed suggested that the perforation was induced by an unknown object from the inside to the outside.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 has been verified.However, it remains unknown how the needle damaged the dilator.

• 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: 3965971
• MDR Text Key: 4626664
• Report Number: 2029046-2014-00218
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup,Followup
• Report Date: 07/10/2014

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?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/10/2014
• Initial Date FDA Received: 07/30/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 08/27/2014; 12/02/2014; 12/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1