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	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During icd implant procedure, an axillary vein was punctured and at the time of passing the guidewire it did not pass through the needle and was stuck.Another angiographic needle and another short guidewire were used, the same peel away was used.A new puncture of the left subclavian vein is required due to inadequate functioning of the needle and the guidewire, with the guidewire getting stuck in the lumen of the needle.
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 insertion difficulties and subsequent device replacement remain unknown.
Additional Manufacturer Narrative
One 7f peel-away introducer guidewire and needle with cover were received for evaluation.The proximal end of the guidewire was pulled to remove the guidewire from the needle; resistance was noted due to a reddish/black foreign material (fm) attached to the guidewire surface, however, the guidewire was able to be removed.Additional testing revealed the returned fm appeared to match generic biological material.The guidewire outside diameter and needle inside diameter measurements were consistent with manufacturing specifications.The guidewire was able to be inserted fully through the returned needle after the fm was removed.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the guidewire stuck is consistent with the biological material on the guidewire.The cause of the biological material on the guidewire remains unknown.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14116741
• Report Number: 3005334138-2022-00260
• Device Sequence Number: 14026051
• Product Code: DYB
• UDI-Device Identifier: 05414734204101
• UDI-Public: 05414734204101
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/04/2022

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 Model Number: 405108
• Device Catalogue Number: 405108
• Device Lot Number: 8203383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2022
• Supplement Date Received by Manufacturer: 05/17/2022; 06/28/2022
• Initial Report FDA Received Date: 04/15/2022
• Supplement Report FDA Received Date: 05/23/2022; 07/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 70 KG