MAUDE Adverse Event Report: ST. JUDE MEDICAL PEEL-AWAY INTRODUCER 14 CM SHEATH INTRODUCER KIT, 8F; INTRODUCER, CATHETER

Model Number	405116
Medical Device Problem Codes	Fracture (1260); Difficult to Insert (1316)
Health Effect - Clinical Codes	Hematoma (1884); Pneumothorax (2012)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
During an implantable cardioverter-defibrillator procedure, the sheath peeled at the distal end while being inserted.Following the procedure, a pneumothorax and a compartment hematoma were noted.
Event or Problem Description
During an implantable cardioverter-defibrillator procedure, the sheath peeled at the distal end while being inserted.The sheath was replaced and the procedure was completed.Following the procedure, a pneumothorax was diagnosed via x-ray and a compartment hematoma were noted.The vascular puncture was noted to be closed normally.The patient was sent to intensive care for closer monitoring.
Additional Manufacturer Narrative
Additional information: g3, h2, h6.
Additional Manufacturer Narrative
One 8f peel-away introducer sheath was received for evaluation.The dilator was also received.The reported event of the ¿sheath peeled at the distal end while being inserted¿ was confirmed.The sheath distal tip had been split along both scorelines; the sheath distal tip had been split and there were multiple bends throughout the sheath tubing distal end.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported hematoma and pneumothorax remains unknown.The cause of the ¿sheath peeled at the distal end while being inserted¿ is consistent with damage during use.

• Brand Name: PEEL-AWAY INTRODUCER 14 CM SHEATH INTRODUCER KIT, 8F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11019261
• Report Number: 3005334138-2020-00608
• Device Sequence Number: 14196973
• Product Code: DYB
• UDI-Device Identifier: 05414734204125
• UDI-Public: (01)05414734204125(10)7258781(17)221031
• 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,Followup,Followup
• Report Date (Section B): 02/18/2021

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: 10/31/2022
• Device Model Number: 405116
• Device Catalogue Number: 405112
• Device Lot Number: 7258781
• 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: 12/15/2020; 02/18/2021; 02/18/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 01/08/2021; 02/18/2021; 02/18/2021
• 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: Other