MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. PEEL-AWAY INTRODUCER, 7F TW, DI-LOCK, 14CM; WIRE, GUIDE, CATHETER

Model Number 405154

Device Problem Difficult to Insert (1316)

Patient Problem Hematoma (1884)

Event Date 08/20/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The guidewire and needle assembly from a peel-away introducer kit were received for evaluation.The results of the investigation confirmed that the guidewire was unable to be fully advanced through the length of the cannula needle due to a build-up of a dried blood proximal to its distal tip.The guidewire outside diameter and needle inside diameter measurements were consistent with manufacturing specifications.A guidewire from current sjm inventory was successfully advanced through the full length of the returned needle.The device met specifications prior to leaving sjm manufacturing facilities as supported by a review of the device history record and the analysis performed the cause of the reported guidewire insertion difficulties through the needle is consistent with damage to the device during use.Per the ifu, hematoma formation is a known risk during the use of this device.

Event Description

Following an electrophysiology procedure, a hematoma occurred.During the procedure using a peel away introducer kit, there was difficulty inserting the guidewire through the puncture needle.After the device was replaced and the procedure was successfully completed, a hematoma was found at the insertion site of the left subclavian vein.The hematoma was evacuated and the patient remained stable.The patient had no symptoms related to the event.

• Brand Name: PEEL-AWAY INTRODUCER, 7F TW, DI-LOCK, 14CM
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5070895
• MDR Text Key: 25551578
• Report Number: 3005188751-2015-00096
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K791129
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 08/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: 405154
• Device Lot Number: 4707751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2014
• 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 Outcome(s): Required Intervention