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

Model Number	405154
Medical Device Problem Codes	Difficult to Insert (1316); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/19/2020
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 the procedure, the rv electrode was attempted to be inserted through the introducer.When the rv electrode was inserted, resistance was felt after being inserted a couple of centimeters.The electrode was removed from the introducer and then the introducer was removed from the patient.A small hole was noted in the middle of the introducer.When originally unpacking the sheath, no hole was noted.Moreover, when inserting the sheath into the vein with the dilator, no issues were noted.The cephalic vein could no longer be used due to the sluice, and then it started bleeding.The bleeding was able to be controlled by applying pressure.The subclavian vein was then used, and the rv electrode was successfully implanted with a new introducer.After sewing the electrode into the tissue, the patient bled over the puncture site of the subclavian.Bleeding through the sheath on the cephalic membrane could not be ruled out by the physician.The bleeding was also stopped via manual pressure.The patient was noted to be stable during the event.
Additional Manufacturer Narrative
One 7f peel-away introducer sheath was received for evaluation.The dilator and guidewire were also received.The reported event of ¿the rv electrode was inserted and "resistance was felt" could not be confirmed.The sheath tubing had been split and stretched at the medial section along the score line, consistent with the reported event.The sheath tubing was also bent and kinked.No anomalies were noted when the returned dilator was inserted through the sheath.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event of ¿the rv electrode was inserted and "resistance was felt" remains unknown.The cause of the sheath tubing split is consistent with damage during use.

• Brand Name: PEEL-AWAY INTRODUCER, 7F TW, DI-LOCK, 14CM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10901143
• Report Number: 3005334138-2020-00590
• Device Sequence Number: 11382269
• Product Code: DYB
• UDI-Device Identifier: 05414734204415
• UDI-Public: 05414734204415
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 02/23/2021

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: 07/31/2022
• Device Model Number: 405154
• Device Catalogue Number: 405154
• Device Lot Number: 7134687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/19/2020
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention