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

Model Number	SENSH1628W
Medical Device Problem Codes	Component Missing (2306); Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Image review summary: a photograph was returned for evaluation, upon of review of the photograph, it was confirmed that the dilator was not present in tray with the sheath, could not determine the cause of the missing dilator.In addition, both clips which were holding down the sheath and normally would be holding down the dilator were seen attached to the tray.However, the sheath appeared to have been removed and placed back into the incorrect location on the tray prior to taking the photographs.No obvious defects with the sheath or tray were visible.A photograph showing the label end of the opened carton did not reveal anything obvious to show that the carton may have been tampered with or help determine the cause of the missing dilator.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A sentrant was being prepared to be used for a patient in an emergency procedure.It was reported that a dilator was not packed in the package.The procedure was completed with the use of another product.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Device evaluation summary: the product tray, pouch and shelf carton were returned.The product pouch had previously been opened.The sentrant sheath was positioned in the tray.Two tray clips were loose in the tray.The dilator was not present in the tray.There was no damage observed to the sheath.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
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 CARDIOVASCULAR; 3576 unocal place; santa rosa CA 95403
• MDR Report Key: 7241053
• Report Number: 2953200-2018-00184
• Device Sequence Number: 10971363
• Product Code: DYB
• UDI-Device Identifier: 00643169150324
• UDI-Public: 00643169150324
• 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,Followup,Followup,Followup
• Report Date (Section B): 10/05/2018

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: 07/04/2018
• Device Model Number: SENSH1628W
• Device Catalogue Number: SENSH1628W
• Device Lot Number: 00124922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Initial Date Received by Manufacturer: 01/15/2018
• Supplement Date Received by Manufacturer: 04/30/2018; 06/13/2018; 08/08/2018
• Initial Report FDA Received Date: 02/05/2018
• Supplement Report FDA Received Date: 05/24/2018; 08/08/2018; 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1