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

Model Number	407655
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
During the procedure, a piece of the device broke off after being inserted into the patient's anatomy.The femoral vein was difficult to puncture and a stiff guidewire was used to introduce the introducer.When the dilator was removed from the patient, the tip was noted to be split and broken and a piece of the device was missing.The missing piece was unable to be found and it was unknown if the device broke inside the patient's anatomy.The device was replaced with no adverse patient consequences.
Additional Manufacturer Narrative
One 12f ultimum ev introducer sheath and dilator were received for evaluation.The dilator distal tip had been split and torn; scratches were visible inside the dilator distal tip.The torn section of the dilator tubing had a whitish color and indentations consistent with abrasion and stress-related damage.No loose material was returned, however, there appeared to be missing material at the location of the dilator damage.There was no visible damage to the sheath distal tip.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the split and torn dilator tip is consistent with damage during use.

• Brand Name: ULTIMUM HEMOSTASIS INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8971537
• Report Number: 3005334138-2019-00486
• Device Sequence Number: 16790593
• Product Code: DYB
• UDI-Device Identifier: 05414734011259
• UDI-Public: 05414734011259
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K023447
• 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): 10/04/2019

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: 08/31/2019
• Device Model Number: 407655
• Device Lot Number: 5638567
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1