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

Model Number	SENSH1828W
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2018
Type of Reportable Event	Malfunction
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 in the endovascular treatment of a patient.It was reported that during the index procedure there was a leak from the valve around the inserted guidewire.As per the physician the cause of the event was due to a defective valve.It was noted that a second 18fr sheath was opened and used successfully to resolve the event.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Device evaluation summary: upon return of the device it was noted that the tip of the sheath was partially flattened and oval.The sheath was flushed with no leak observed.The side leg tubing was removed; no anomaly was observed to the sheath port which could have resulted in the reported leak.A review of the device manufacturing documentation did not reveal any anomalies which may have contributed to the reported event.From the information provided the exact cause of the event cannot conclusively be determined.The device was returned for analysis.The sheath was flushed with no leak observed.The event was not confirmed.While there was some damage to the tip noted which would be consistent with use during.No anomaly was observed to the seal that could explain the reported leak.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SENTRANT INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway,ie
• MDR Report Key: 7217932
• Report Number: 2953200-2018-00139
• Device Sequence Number: 99960
• Product Code: DYB
• UDI-Device Identifier: 00643169150331
• UDI-Public: 00643169150331
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K123990
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: SENSH1828W
• Device Catalogue Number: SENSH1828W
• Device Lot Number: 00125355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Initial Date Received by Manufacturer: 01/04/2018
• Supplement Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 01/25/2018
• Supplement Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR