MAUDE Adverse Event Report: ST. JUDE MEDICAL INTRODUCER UNKNOWN; INTRODUCER, CATHETER

Device Problems Kinked (1339); Difficult To Position (1467)

Patient Problem Vascular Dissection (3160)

Event Date 02/13/2018

Event Type  Injury  

Manufacturer Narrative

Product evaluation: the reported event of a "kink in the anatomy of the device" could not be confirmed.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The ultimum hemostasis introducer sheath instruction for use (ifu) states that the user should advance the dilator/sheath assembly with a twisting motion to avoid damage to the sheath or vessel.The ultimum hemostasis introducer sheath instruction for use (ifu) cautions that individual patient anatomy and physician technique may require procedural variations.

Event Description

When attempting a cardiomems implant, puncture was not successful on both left and right femoral veins.The puncture sites were pre-dilated with a 6f, 7f, and 9f non-abbott products.A 12 f ultimum introducer was used on each side for the bilateral punctures.The patient's anatomy complicated access and dissections were caused on both sides.Ultrasound was used for femoral venous access.The vessels were kinky and narrow and it cannot be confirmed that the introducers are the reason for the dissections.Please reference 3005334138-2018-00108 for other mdr.

Manufacturer Narrative

Product evaluation: an event of dissection could not be confirmed.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

When attempting a cardiomems implant, puncture was not successful on both left and right femoral veins.The puncture sites were pre-dilated with a 6f, 7f, and 9f non-abbott products.A 12 f ultimum introducer was used on each side for the bilateral punctures.The patient's anatomy complicated access and dissections were caused on both sides.Ultrasound was used for femoral venous access.The vessels were kinky and narrow and it cannot be confirmed that the introducers are the reason for the dissections.

• Brand Name: INTRODUCER UNKNOWN
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7441304
• MDR Text Key: 105847079
• Report Number: 3005334138-2018-00109
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K001346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Required Intervention