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

Model Number SENSH1628W

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2019

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 when the sentrant was unpacked, it was noted that the device dilator was not inserted.As the sentrant could not be used without the dilator, a replacement sheath was used to complete the procedure.Per the physician the cause of the event was a defect during product packaging.No clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Additional information received: it is unknown whether there was damage seen on the carton, whether the clear end seal of the carton was intact and whether the sterile seal was found intact.It was reported that the same person that noticed the missing dilator opened the package.Photo evaluation summary one photo was received from the account.The photo shows the sentrant sheath in the packaging tray without the dilator.The tab to hold the dilator in place is correctly positioned in the tray.Two (2) dilators are visible on the table also.Device evaluation summary the sentrant sheath returned loaded in the packaging tray.The shelf carton and packaging pouch were returned.The dilator was not present in the tray.The tab to hold the dilator in place was correctly positioned in the tray.There was no damage observed to the shelf carton.The end tab had previously been removed from the unopened side of the shelf carton.The reported missing component was confirmed through analysis.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: 9353232
• MDR Text Key: 170791701
• Report Number: 9612164-2019-04838
• 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,Followup
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SENSH1628W
• Device Catalogue Number: SENSH1628W
• Device Lot Number: 00142604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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