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 Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.Further information was requested but not received.
Event or Problem Description
During the procedure, a portion of the sheath tip detached and remained in the patient.Upon completion of transseptal puncture, the sl2 sheath was exchanged for a sl1 to continue the atrial fibrillation ablation procedure.Upon removal of the sl2 sheath, it broke and a portion of the tip remained inside the patient and the procedure was aborted.The tip was confirmed to be in the groin area via fluoroscopy and a vascular surgeon was called in to remove the detached portion.The tip of the sheath was removed successfully and the patient is in stable condition.
Event or Problem Description
The device was retrieved with a hemostat by the vascular surgeons with all pieces accounted for via fluoroscopy.
Additional Manufacturer Narrative
Images provided appeared to show he sheath tip was fractured and detached.The sheath material appeared to be yellowed and had a cracked, egg-shell appearance.The damage is consistent with the product being stored outside of the shelf box and exposed to light.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The product instructions for use (ifu), warns that product should be stored in a cool, dark, dry place.The cause of the degradation is consistent with not following the instructions for 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: 10935403
• Report Number: 3005334138-2020-00605
• Device Sequence Number: 11343482
• Product Code: DYB
• UDI-Device Identifier: 05414734205795
• UDI-Public: 05414734205795
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K052644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/02/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 407455
• Device Catalogue Number: 407455
• Device Lot Number: 6416120
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 12/07/2020; 02/02/2021
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 12/17/2020; 02/02/2021
• 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: Required Intervention
• Patient Age: 69 YR
• Patient Weight: 133