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

Model Number SENSH1828W

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Low Blood Pressure/ Hypotension (1914); Perforation (2001); Perforation of Vessels (2135)

Event Date 10/16/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A sentrant sheath was used as a conduit during an endovascular aneurysm repair (evar) procedure.Due to severe bilateral iliac tortuosity and a right common iliac aneurysm, evar was scheduled after embolization of the right internal iliac artery coil.It was reported during the index procedure, the catheter was attempted to be advanced from the ipsilateral cannulation site but manipulation of the catheter could not be performed adequately due to severe iliac tortuosity.Right iia cannulation was attempted from the contralateral side (left) however again due to severe iliac tortuosity difficulty was encountered in manipulating the catheter.The 18fr sentrant was inserted and brought up to the terminal aorta and cannulation of the right iia was continued however the sentrant sheath dislodged downwards to the distal side due to the difficulties in cannulation and advancement.While inserting the sheath again and advancing to the terminal aorta, the left eia was damaged.The patient's blood pressure dropped and occlusion was performed with a reliant balloon (rel46j) from the right side.At this time the physician decided to convert to open and placed an abdominal artificial blood vessel and completed the procedure.Per the physician the cause of the vessel damage was anatomy related due severe iliac tortuosity which restricted manipulation of the catheter.It was also noted that user error may have contributed including the size of the sheath used during the procedure.No additional clinical sequelae were reported and the patient is fine.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: SENTRANT INTRODUCER SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway,ie
• MDR Report Key: 10790631
• MDR Text Key: 214724416
• Report Number: 9612164-2020-04252
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K123990
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2021
• Device Model Number: SENSH1828W
• Device Catalogue Number: SENSH1828W
• Device Lot Number: 00152192
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR