MAUDE Adverse Event Report: ST. JUDE MEDICAL PEEL-AWAY INTRODUCER 14 CM SHEATH INTRODUCER KIT, 7F; INTRODUCER, CATHETER

Model Number	405108
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	12/20/2018
Type of Reportable Event	Death
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 patient death remains unknown. .
Event or Problem Description
Related manufacturing ref: 2017865-2018-19534, 2017865-2018-19537, 2017865-2018-19539.Following a pacemaker implant on (b)(6) 2018, the patient expired the following day.The cause of death is unknown and no further information is available.

• Brand Name: PEEL-AWAY INTRODUCER 14 CM SHEATH INTRODUCER KIT, 7F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8218446
• Report Number: 3005334138-2018-00526
• Device Sequence Number: 1670441
• Product Code: DYB
• UDI-Device Identifier: 05414734204101
• UDI-Public: 05414734204101
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K791129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/04/2019

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: 07/31/2021
• Device Model Number: 405108
• Device Catalogue Number: 405108
• Device Lot Number: 6598410
• 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: 12/20/2018
• Initial Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1888TC/58 CM TENDRILLEAD; 5816 VICTORY XL DRPACEMAKER; ISOFLEX OPTIM 1944/52CMLEADS
• Outcome Attributed to Adverse Event: Death
• Patient Age: 67 YR