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

Model Number	405104
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/09/2020
Type of Reportable Event	Malfunction
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 the procedure, following access to the vein, and the wire being inserted through the needle, the needle could not be pulled back.The needle and the wire had to be removed together.An additional puncture was required since the devices had to be removed.The introducer was replaced to complete the procedure with no patient consequences.
Event or Problem Description
Upon receipt of the device, tissue was noted to be attached.However, there were no patient consequences and no additional intervention required.
Additional Manufacturer Narrative
One peel-away introducer 14cm sheath introducer kit, 6f was received for investigation the distal end of the guidewire was pulled to remove the guidewire from the needle; resistance was noted due to dried bls and a tissue-like substance, however, the guidewire was able to be removed.The guidewire outside diameter and needle inside diameter measurements were consistent with manufacturing specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported withdrawal difficulty and subsequent additional puncture is consistent with damage during use.

• Brand Name: PEEL-AWAY INTRODUCER 14CM SHEATH INTRODUCER KIT, 6F
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10183611
• Report Number: 3005334138-2020-00249
• Device Sequence Number: 16370956
• Product Code: DYB
• UDI-Device Identifier: 05414734204088
• UDI-Public: 05414734204088
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K894431
• 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,Followup
• Report Date (Section B): 08/14/2020

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: 08/31/2022
• Device Model Number: 405104
• Device Catalogue Number: 405104
• Device Lot Number: 7196466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 08/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1