MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH HEMOSTASIS INTRODUCER, CATH-LOCK LOCKING HUB, 12 CM SHEATH, 7 F; INTRODUCER, CATHETER

Model Number	406702
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	03/29/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrial fibrillation ablation procedure utilizing a femoral access site, when attempting to remove the sheath resistance was noted and when fully removed from the patient, a part of the sheath was left in the patient.A snare was used to remove the broken off piece and there were no adverse consequences to the patient.The procedure was still noted to have been completed.All of the pieces were accounted for with both fluoroscopy and echocardiogram.No insertion difficulties or anatomical issues were noticed when introducing the introducer.
Additional Manufacturer Narrative
One 7f fast-cath introducer sheath was received for evaluation.The sheath tube had been torn and separated.The distal portion of the sheath was not returned.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the torn sheath is consistent with damage during use.

• Brand Name: FAST-CATH HEMOSTASIS INTRODUCER, CATH-LOCK LOCKING HUB, 12 CM SHEATH, 7 F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11657799
• Report Number: 3005334138-2021-00230
• Device Sequence Number: 14492553
• Product Code: DYB
• UDI-Device Identifier: 05414734216951
• UDI-Public: 05414734216951
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K061015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 406702
• Device Catalogue Number: 406702
• Device Lot Number: 7360339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 05/17/2021
• 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: 55 YR