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

Model Number	406804
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
During a procedure the needle perforated the side of the sheath when being inserted.The sheath was replaced and the procedure was completed with no adverse consequences to the patient.
Additional Manufacturer Narrative
One 8.5f agilis steerable introducer sheath was received for evaluation with the dilator partially inserted.Visual inspection revealed the dilator had perforated the sheath tubing and the sheath tubing had been stretched and torn in one location within the manufactured curve.The sideport orientation of the sheath was consistent with specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The damage to the sheath is consistent with forcible contact between the dilator and the inner diameter of the sheath during dilator insertion.

• Brand Name: FAST-CATH¿ TRANSSEPTAL GUIDING INTRODUCER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8304860
• Report Number: 3005334138-2019-00054
• Device Sequence Number: 11049740
• Product Code: DYB
• UDI-Device Identifier: 05414734203302
• UDI-Public: 05414734203302
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K920327
• 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): 03/21/2019

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: 04/30/2021
• Device Model Number: 406804
• Device Catalogue Number: 406804
• Device Lot Number: 6436899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/18/2019
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 03/21/2019
• 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: Other