MAUDE Adverse Event Report: MEDTRONIC, INC INPUT TS INTRODUCER SHEATH 8F; INTRODUCER, CATHETER

Catalog Number	081102A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/11/2018
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
An 8f input ts device was intended to be used during a procedure.Upon removal of the 8f introducer, it was observed that the tip of the input ts device was broken, leaving the entire extension of the device in the patient's femoral vein.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: INPUT TS INTRODUCER SHEATH 8F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 7669165
• Report Number: 1220452-2018-00087
• Device Sequence Number: 11104927
• Product Code: DYB
• UDI-Device Identifier: 20643169014453
• UDI-Public: 20643169014453
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K955785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2018

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: 08/28/2020
• Device Catalogue Number: 081102A
• Device Lot Number: 51030672
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/04/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1