MAUDE Adverse Event Report: ST. JUDE MEDICAL (AFD-PLYMOUTH) PEEL-AWAY INTRODUCER 14CM SHEATH INTRODUCER KIT, 6F; INTRODUCER, CATHETER

Model Number	405104
Medical Device Problem Codes	Difficult to Insert (1316); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
During a device replacement and rv lead placement procedure, the case was cancelled.The tip of the sheath was bent when inserting into the right subclavian vein, and it could not be inserted.The introducer was replaced and peeled, but the lead could not advance to the target position.The replacement introducer also became bent during use.The procedure was rescheduled, and the sheath would be inserted via the left subclavian vein.
Additional Manufacturer Narrative
The reported event of "the lead could not advance to the target position" could not be confirmed.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 incident could not be conclusively determined.
Additional Manufacturer Narrative
One 6f peel away introducer sheath and dilator were received for evaluation.No anomalies, including the reported bend, were noted on the returned dilator.The sheath tubing had been fully peeled along the intended scorelines.Functional testing was not possible due to the returned condition of the device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the received condition of the device and the information provided, the cause of the reported insertion difficulty and bend remains unknown.

• Brand Name: PEEL-AWAY INTRODUCER 14CM SHEATH INTRODUCER KIT, 6F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL (AFD-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10935980
• Report Number: 3005334138-2020-00591
• Device Sequence Number: 2322504
• Product Code: DYB
• UDI-Device Identifier: 05414734204088
• UDI-Public: 05414734204088
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/04/2021

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: No Information
• Device Expiration Date: 09/30/2022
• Device Model Number: 405104
• Device Catalogue Number: 405104
• Device Lot Number: 7213811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 12/02/2020; 02/02/2021
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 12/08/2020; 02/04/2021
• 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