MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL1, 81 CM LENGTH, 8.5F; INTRODUCER, CATHETER

Model Number	407454
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2020
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
Related manufacturer reference: 3005334138-2020-00235, 3008452825-2020-00329, 3008452825-2020-00330.During a procedure, resistance was noted while trying to advance the brk needle.Force was needed to advance the device.The sheath and needle were replaced, and again the issue was noted.The devices were replaced a third time and resolution was found to complete the procedure.There were no patient consequences.No additional access site was required, however a clinically significant delay of 20-30 minutes was noted.
Additional Manufacturer Narrative
One swartz¿ braided transseptal guiding introducer, sl1¿, 81 cm length, 8.5f was received for investigation.Resistance was noted near the distal end of the dilator when a brk needle/stylet assembly from current inventory was advanced through the returned dilator and sheath.The dilator tubing was cut lengthwise and skived material was noted at the distal end of the dilator.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 skiving remains unknown.

• Brand Name: SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL1, 81 CM LENGTH, 8.5F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10204360
• Report Number: 3005334138-2020-00261
• Device Sequence Number: 1073550
• Product Code: DYB
• UDI-Device Identifier: 05414734205788
• UDI-Public: 05414734205788
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K052644
• 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): 07/29/2020

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: 09/30/2022
• Device Model Number: 407454
• Device Catalogue Number: 407454
• Device Lot Number: 7236750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 06/27/2020
• Supplement Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BRK-1¿ TRANSSEPTAL NEEDLE (X2); SWARTZ¿ BRAIDED TRANSSEPTAL GUIDING INTRODUCER
• Outcome Attributed to Adverse Event: Other
• Patient Age: 44 YR