MAUDE Adverse Event Report: ST. JUDE MEDICAL (CVD-PLYMOUTH) MAXIMUM HEMOSTASIS INTRODUCER; INTRODUCER, CATHETER

Model Number	406665
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The sheath of the maximum hemostasis introducer splintered as it was pulled out of the patient.
Additional Manufacturer Narrative
The reported event of "sheath of the maximum hemostasis introducer split as it was pulled out of the patient" could not be confirmed.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.The maximum introducer instructions for use (ifu) states that damage to the valve assembly may occur if inner catheter is withdrawn rapidly.Additionally, the (ifu) cautions that upon removal of the hemostasis introducer proper precautions should be taken to prevent bleeding.
Event or Problem Description
The sheath of the maximum hemostasis introducer split as it was pulled out of the patient as part of a completed procedure.

• Brand Name: MAXIMUM HEMOSTASIS INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL (CVD-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7878442
• Report Number: 3005334138-2018-00322
• Device Sequence Number: 13908191
• Product Code: DYB
• UDI-Device Identifier: 05414734015561
• UDI-Public: 05414734015561
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K870374
• 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): 12/03/2018

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: 03/31/2021
• Device Model Number: 406665
• Device Catalogue Number: 406665
• Device Lot Number: 6398638
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/07/2018
• Supplement Date Received by Manufacturer: 09/27/2018; 11/29/2018
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 10/12/2018; 12/03/2018
• 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: Other
• Patient Age: 77 YR
• Patient Weight: 66