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

Model Number SENSH1828W

Device Problems Difficult or Delayed Positioning (1157); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A sentrant sheath was intended to be used as an accessory device for the endovascular treatment of a patient.  it was reported that during the index procedure, the 18 fr sentrant would not track up the vessel.The physician attempted to insert with steady pressure, however was not successful.It was noted that the endurant 32 main body stent graft used was 20 fr and had been inserted previously and removed without issues.The physician removed the sentrant from the patient, and noted that it seemed to not be covered with hydrophilic coating and felt almost rough to the touch.The device was replaced with a 16 fr sheath, which was inserted and tracked up the vessel with no issues.Per the physician the cause of the event could not be determined.No clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Device evaluation summary: coating presence on the surface of the sheath was confirmed by wetting the sheath prior to processing through decontamination.The sentrant sheath and dilator were returned for evaluation.Longitudinal scratches were visible on the tip of the sheath.Indentations in a radial pattern were visible extending three-quarters of the way around the circumference of the tip.Tactile test confirmed slight roughness on the first four (4) cm proximal to the tip.The reported coating issue was unconfirmed through analysis.Additional information received: it was clarified that the endurant 32 main body was not attempted to be passed through the 18f sheath.Anatomy was noted to have been 'unremarkable' with no mention of stenosis.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,ie
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway,ie
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; 091708096
• MDR Report Key: 9389818
• MDR Text Key: 186835701
• Report Number: 9612164-2019-04937
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: SENSH1828W
• Device Catalogue Number: SENSH1828W
• Device Lot Number: 00140510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2019
• 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: 84 YR