MAUDE Adverse Event Report: COOK INC PERFORMER MULLINS GUIDING SHEATH; DYB INTRODUCER, CATHETER

Model Number G08133

Device Problems Split (2537); Malposition of Device (2616)

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

Event Date 12/24/2015

Event Type  malfunction  

Manufacturer Narrative

This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.

Event Description

It was reported during the patient's electrophysiology/ablation procedure, upon advancing the dilator into the sheath, trans-thoracic and x-ray imaging identified the introducer sheath was not moving in the usual angles.As a result, the introducer was immediately removed from the patient.Subsequently, the sheath was confirmed to be split at the distal end by the dilator which exited through the side of the sheath rather than the end hole.As a result, the sheath and dilator were removed and exchanged.It was noted that no harm was caused to the patient as trans-thoracic echo revealed no damage/effusion.Additionally, it was noted the dilator and sheath were flushed and prepared before being advanced into the patient.Also, it was clarified that upon determining the sheath was not in the correct place, the dilator was removed, re-introduced and upon re-imaging the issue with the dilator and sheath was identified.

• Brand Name: PERFORMER MULLINS GUIDING SHEATH
• Type of Device: DYB INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6932049
• MDR Text Key: 90156711
• Report Number: 1820334-2017-03378
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00827002081338
• UDI-Public: (01)00827002081338(17)180514(10)5885484
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G08133
• Device Catalogue Number: RCFW-8.0-38-63-RB-MTS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2015
• 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
• Patient Age: 44 YR