MAUDE Adverse Event Report: ST. JUDE MEDICAL PEEL-AWAY INTRODUCER 14CM SHEATH INTRODUCER KIT, 9F; INTRODUCER, CATHETER

Model Number	405116
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2020
Type of Reportable Event	Malfunction
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 an implantable cardiac defibrillator procedure (icd), sheath damage occurred during insertion into the subclavian along a standard guide.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
One 9f peel-away introducer sheath was received for evaluation.The sheath distal tip had been split in multiple locations, including along the intended scorelines.The dilator was inserted into the sheath the device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the split sheath tip is consistent with damage during use.

• Brand Name: PEEL-AWAY INTRODUCER 14CM SHEATH INTRODUCER KIT, 9F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10969972
• Report Number: 3005334138-2020-00615
• Device Sequence Number: 2178098
• Product Code: DYB
• UDI-Device Identifier: 05414734204149
• UDI-Public: 05414734204149
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K894431
• 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): 02/08/2021

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 Expiration Date: 11/30/2022
• Device Model Number: 405116
• Device Catalogue Number: 405116
• Device Lot Number: 7299679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 02/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1