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

Model Number	406114
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2019
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 hole was noticed in the sheath.The procedure was completed using the swan-ganz for catheter insertion to continue ablation with no adverse patient consequences.
Additional Manufacturer Narrative
One 8f fast-cath introducer with luer lock sheath was received for evaluation.One image was also submitted for evaluation to product performance engineering.The sheath tubing had been bent in a curve, had multiple kinks, and had been perforated and kinked at the same location.Functional testing could not be conducted due to the multiple kinks throughout the sheath tubing.The returned photo indicated the location of the sheath puncture site, which is consistent with the sheath perforation noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event is consistent with damage during use.

• 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: 9458572
• Report Number: 3005334138-2019-00801
• Device Sequence Number: 19602354
• Product Code: DYB
• UDI-Device Identifier: 05414734013932
• UDI-Public: 05414734013932
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K914090
• 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): 02/07/2020

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: 12/31/2020
• Device Model Number: 406114
• Device Catalogue Number: 406114
• Device Lot Number: 6298701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1