MAUDE Adverse Event Report: ST. JUDE MEDICAL FAST-CATH¿; INTRODUCER, CATHETER

Model Number	406965
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturing ref: 3008452825-2022-00194.Following the procedure, an attempt was made to pull back the catheter while the sheath was still in the inferior vena cava.Resistance was noted and it was advised to pull the equipment out under fluoroscopy.When attempting to pull the equipment back again, it was noted that the catheter was looped around the sheath and the catheter had sheared off part of the sheath when it was originally pulled back.All of the sheath pieces of the sheath were recovered with no consequences to the patient.
Additional Manufacturer Narrative
Two images were submitted for evaluation to product performance engineering.One image appears to show a non-abbott introducer sheath.A portion of the sheath has been fractured and detached and is not present in the photo.Specifically, the sheath appears to have been sliced lengthwise along the sheath.The other image appears to show an advisor hd grid catheter.A portion of the introducer sheath has been fractured and detached, and is caught on the splines of the advisor hd grid catheter.
Event or Problem Description
Further information revealed a non-abbott sheath was involved in this event, not a fast cath introducer.

• Brand Name: FAST-CATH¿
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13967889
• Report Number: 3005334138-2022-00271
• Device Sequence Number: 20097050
• Product Code: DYB
• UDI-Device Identifier: 05414734203159
• UDI-Public: 05414734203159
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 406965
• Device Catalogue Number: 406965
• Device Lot Number: 8093697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2022
• Supplement Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ADVISOR¿ HD GRID MAPPING CATHETER, SE
• Patient Sex: Unknown