MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿ HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 6.5 F; INTRODUCER, CATHETER

Model Number	406704
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Hematoma (1884); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrial fibrillation ablation procedure a portion of the sheath became detached inside the patient.The 6.5f sheath was introduced into the vein but there was some insertion difficulty with attempting to insert the 4f catheter into the sheath.After the procedure was completed a small hematoma was noted and when the sheath was removed the valve became detached and the sheath remained in the vein.Intervention was performed to remove the remainder of the sheath, which was confirmed on fluoroscopy and echocardiogram.
Additional Manufacturer Narrative
One 6.5f fast-cath introducer sheath was received for evaluation.The sheath tubing had been torn and a section had been detached near the sheath hub.The attached tubing distal end appearance had similar damage, consistent with a mating surface to the aforementioned detached tubing.The distal detached section of the sheath tubing had multiple kinks, had been flattened, and appeared partially stretched/torn and partially dissected.No anomalies were noted when a 6.5f dilator was advanced through the returned sheath hub and the proximal section of the fractured sheath tubing.Dimension inspection confirmed the sheath distal tip inside diameter met specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of reported event of ¿the sheath became detached¿ is consistent with damage during use.Based on the received condition of the device and the information provided, the cause of the reported catheter insertion difficulties remains unknown.

• Brand Name: FAST-CATH¿ HEMOSTASIS INTRODUCER, CATH-LOCK¿ LOCKING HUB, 12 CM SHEATH, 6.5 F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8362776
• Report Number: 3005334138-2019-00106
• Device Sequence Number: 1867090
• Product Code: DYB
• UDI-Device Identifier: 05414734216975
• UDI-Public: 05414734216975
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K894343
• 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): 03/25/2019

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: 08/31/2021
• Device Model Number: 406704
• Device Catalogue Number: 406704
• Device Lot Number: 6669570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/12/2019
• Supplement Date Received by Manufacturer: 03/23/2019
• Initial Report FDA Received Date: 02/22/2019
• Supplement Report FDA Received Date: 03/25/2019
• 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: Required Intervention
• Patient Age: 66 YR