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

Model Number	SENSH2028W
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Film evaluation summary: the complaint was confirmed; there was a kink in the dilator tip.The exact cause of the event cannot be conclusively determined.Device evaluation summary: the complaint was confirmed; there was a kink in the dilator near the tip.The exact cause of the event cannot be conclusively determined.
Event or Problem Description
A sentrant sheath was attempted to be used in a patient for the endovascular treatment of an abdominal aortic aneurysm.It was reported that the tip of the dilator was damaged in the packaging.The surgeon noticed this while prepping the device.The dilator was snapped in place when the package was opened and there was no visible damage to the box or container.Another sheath was opened and the procedure was completed successfully.The physician stated that the cause of the event was device related.No clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Additional evaluation summary: teleflex deemed the kink to be most likely due to handling damage during unpacking/preparation/insertion through the sheath and that the event was not related to the manufacturing process.
Additional Manufacturer Narrative
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: 6538038
• Report Number: 2953200-2017-00710
• Device Sequence Number: 1458035
• Product Code: DYB
• UDI-Device Identifier: 00643169150348
• UDI-Public: 00643169150348
• 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,Followup
• Report Date (Section B): 05/25/2017

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: No Information
• Device Expiration Date: 11/16/2017
• Device Model Number: SENSH2028W
• Device Catalogue Number: SENSH2028W
• Device Lot Number: 00119258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2017
• Initial Date Received by Manufacturer: 04/06/2017
• Supplement Date Received by Manufacturer: Not provided; 05/25/2017
• Initial Report FDA Received Date: 05/02/2017
• Supplement Report FDA Received Date: 06/06/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR