MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH GUIDING INTRODUCER SAFL SERIES, 8.5F; INTRODUCER, CATHETER

Model Number	406868
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
At the end of the procedure, a tear was noted in the body of the sheath when removed from the patient.There were no consequences to the patient.
Additional Manufacturer Narrative
One 8.5f fast-cath introducer sheath was received for evaluation.The sheath had been torn and stretched; the torn sheath material remained attached.No anomalies were noted when a dilator from current inventory was inserted through the sheath.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported damage remains unknown.The cause of the sheath tear is consistent with damage during use.

• Brand Name: FAST-CATH GUIDING INTRODUCER SAFL SERIES, 8.5F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11118052
• Report Number: 3005334138-2021-00007
• Device Sequence Number: 4051219
• Product Code: DYB
• UDI-Device Identifier: 05414734203036
• UDI-Public: 05414734203036
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2021

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: 03/31/2023
• Device Model Number: 406868
• Device Catalogue Number: 406868
• Device Lot Number: 7468430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/04/2021
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1