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

Model Number	SENSH1428W
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Injury (2348); Blood Loss (2597)
Date of Event	05/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A sentrant sheath was used as a conduit device during the endovascular treatment of a 51mm abdominal aortic aneurysm.A short and severely tortuous aneurysmal neck was noted.Moderate calcification was observed in both iliac arteries.It was reported during the index procedure after a limb was contralaterally inserted on left side and deployed, a 14 fr sentrant sheath was inserted and once the dilator was removed continuous leakage was noted from the haemostatic valve.A 16 fr sentrant sheath was subsequently inserted on the main device side with no leakage reported from the haemostatic valve.The physician decided to complete the procedure, remove the sheath, and then stop the bleeding (close the incision) rather than to insert a new sheath because the event occurred at the end of the evar, however prior to closing the incision, blood pressure declined.The decrease in blood pressure was suspected to be due to the leakage from the valve because leakage from stent graft or damage on blood vessels was not observed.Blood pressure was controlled by drugs administered by anaesthesiology and the patient recovered.The bleeding was stopped and the incision closed.Per the physician the cause of the event is suspected to be product related and commented that the leakage issue was not a space leakage as there was no situation where the gw was removed first and nothing was in the sheath.No additional clinical sequelae were reported and the patient is fine.

• Brand Name: SENTRANT INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway,ie
• MDR Report Key: 7568386
• Report Number: 2953200-2018-00802
• Device Sequence Number: 144163
• Product Code: DYB
• UDI-Device Identifier: 00643169150317
• UDI-Public: 00643169150317
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2018
• Device Model Number: SENSH1428W
• Device Catalogue Number: SENSH1428W
• Device Lot Number: 00126507
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR