MAUDE Adverse Event Report: ST. JUDE MEDICAL MAXIMUM HEMOSTASIS INTRODUCER; INTRODUCER, CATHETER

Model Number	406253
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
During the procedure, the introducer hub and sheath separated.The device was retrieved, and another introducer was used to complete the procedure with no adverse patient consequences.
Additional Manufacturer Narrative
One 8f maximum hemostasis introducer dilator was received for evaluation.The sheath tube was separated and torn from the hub.Additional analysis revealed that the sheath also appeared cut in half.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the received condition of the device and the information provided, the cause of the damage is consistent with damage during use.

• Brand Name: MAXIMUM HEMOSTASIS INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8425205
• Report Number: 3005334138-2019-00133
• Device Sequence Number: 19395551
• Product Code: DYB
• UDI-Device Identifier: 05414734008402
• UDI-Public: 05414734008402
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K870374
• 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
• Report Date (Section B): 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 406253
• Device Catalogue Number: 406253
• Device Lot Number: 6660812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/01/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 07/26/2019
• 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: Required Intervention