MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH HEMOSTASIS INTRODUCER; INTRODUCER, CATHETER

Model Number	406120
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	07/08/2020
Type of Reportable Event	Serious Injury
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 transcatheter aortic valve replacement procedure, the sheath split inside the patient's anatomy.The device was removed over a wire.The patient experienced a cardiac tamponade and a pericardiocentesis was performed to stabilize the patient.The procedure was completed using a larger sheath.
Additional Manufacturer Narrative
One 10f fast-cath introducer sheath and dilator were received for evaluation.The sheath had been perforated proximal to the distal tip.The sheath was flushed with fluid and the returned dilator was inserted; no resistance or functional anomalies were noted.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 perforation and reported cardiac tamponade remains unknown.

• Brand Name: FAST-CATH HEMOSTASIS INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10382995
• Report Number: 3005334138-2020-00338
• Device Sequence Number: 11228919
• Product Code: DYB
• UDI-Device Identifier: 05414734008266
• UDI-Public: 05414734008266
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K914090
• 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
• Report Date (Section B): 08/19/2020

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: 08/31/2020
• Device Model Number: 406120
• Device Catalogue Number: 406120
• Device Lot Number: 6135451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 08/08/2020
• Supplement Report FDA Received Date: 08/19/2020
• 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