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: 3005334138-2020-00261, 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.No anomalies were noted when a brk needle/stylet assembly was advanced through the returned sheath/dilator assembly.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported needle insertion difficulty and subsequent delay 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: 10204359
• Report Number: 3005334138-2020-00235
• Device Sequence Number: 19100950
• 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: 02/28/2021
• Device Model Number: 407454
• Device Catalogue Number: 407454
• Device Lot Number: 6366632
• 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