MAUDE Adverse Event Report: ST. JUDE MEDICAL SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL2, 63 CM LENGTH, 8.5 F; INTRODUCER, CATHETER

Model Number	407455
Medical Device Problem Codes	Difficult to Insert (1316); Material Puncture/Hole (1504); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2020
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
During an atrial fibrillation procedure, the introducer was unable to advance across the atrial septum while attempting to gain transseptal access and a clinically significant delay was noted.The introducer was removed and the distal end of the sheath was noted to be bent and punctured.The introducer was replaced and the procedure was completed.A fifteen minute clinically significant delay was noted due to the issue.
Additional Manufacturer Narrative
One 8.5f swartz braided introducer sheath and dilator were received for evaluation.The sheath distal tip had been punctured.The sheath was flushed with fluid and the dilator was inserted and successfully advanced through the entire length of the sheath assembly.No gap was noted at the dilator/sheath transition.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported patient insertion difficulty remains unknown and the cause of the punctured sheath tip is consistent with damage during use.

• Brand Name: SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER, SL2, 63 CM LENGTH, 8.5 F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10563918
• Report Number: 3005334138-2020-00431
• Device Sequence Number: 13745086
• Product Code: DYB
• UDI-Device Identifier: 05414734205795
• UDI-Public: 05414734205795
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 11/10/2020

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: 01/31/2023
• Device Model Number: 407455
• Device Catalogue Number: 407455
• Device Lot Number: 7414629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 11/10/2020
• 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