MAUDE Adverse Event Report: MEDTRONIC IRELAND SENTRANT INTRODUCER SHEATH; INTRODUCER, CATHETER

Model Number SENSH1828W

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2016

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A sentrant sheath and reliant balloon were used in a patient for the endovascular treatment an abdominal aortic aneurysm.It was reported that, when the reliant balloon was being removed from the sentrant sheath during the index procedure, the physician noted that the balloon was caught inside the sheath and burst.After removal, the balloon could not be inflated and was replaced with another manufacturer's device.The physician assessed this event to be related to the device.It was also noted that the resistance was felt during removal of the sentrant sheath from the dilator.Also, resistance was felt during removal of the reliant balloon from the sentrant sheath.The physician suspected there was a possibility of the hemostasis valve of sentrant was damaged.No clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Corrected information: sex.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SENTRANT INTRODUCER SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: eric elliott ; 3576 unocal place; santa rosa, CA 95403 ; 7075912586
• MDR Report Key: 5953949
• MDR Text Key: 54890234
• Report Number: 2953200-2016-01670
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2017
• Device Model Number: SENSH1828W
• Device Catalogue Number: SENSH1828W
• Device Lot Number: 00111720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2016
• Date Device Manufactured: 04/08/2016
• 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