MAUDE Adverse Event Report: ST. JUDE MEDICAL PEEL-AWAY INTRODUCER 23 CM SHEATH, 9F; INTRODUCER, CATHETER

Model Number	405254
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported device fragment could not be conclusively determined.
Event or Problem Description
During a procedure a device fragmentation occurred.At the end of the case, as the sheath was being peeled, the sheath stretched instead of peeled and the material tore leaving approximately 4 inches of the device in the patient.A small dermatotomy was done to insert forceps to retrieve the remaining portion of the device.All pieces were removed from the patient.

• Brand Name: PEEL-AWAY INTRODUCER 23 CM SHEATH, 9F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9125380
• Report Number: 3005334138-2019-00536
• Device Sequence Number: 11337274
• Product Code: DYB
• UDI-Device Identifier: 05414734204590
• UDI-Public: 05414734204590
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K791129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/26/2019

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: 04/30/2021
• Device Model Number: 405254
• Device Catalogue Number: 405254
• Device Lot Number: 6452220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 09/26/2019
• 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