MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. ARROW; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	IPN033530
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Notes from occurrence report: "physician attempted to insert a picc line in the patient's right upper arm.Physician appeared to be having difficulty advancing picc line as the procedure was taking longer than usual and the patient was grimacing.Per rad tech that was assisting physician with the procedure, as physician was peeling away the peel away sheath, a portion of the peel away sheath became detached and remained inside the patient's right upper arm.Patient received ct of right upper extremity, picc line was inserted in left are (with ease), and retained picc line piece was retrieved and removed by physician".Additional note from occurrence report: "spoke with physician and he is confident this was a malfunction of the product.This is being followed up per protocol".Additional notes from emr: "a 21-gauge needle was placed in the target vein and then a peel-away sheath was placed over a guidewire.The picc line catheter was placed through the sheath.However, following removal of the sheath a portion of the distal end broke off and could not be removed from the patient.Given this finding, and inability to advance the picc which was subsequently removed the patient was sent for ct scan of the right upper extremity.Findings of the ct scan demonstrate that the majority of the sheath was subcutaneously/outside of the brachial vein.The patient was then returned to the interventional radiology room and incision was made within the right upper extremity medially and the sheath successfully removed".Per site reporter: manufacturer was made aware.Manufacturer was to show up to take a look at the item.Arrow rep did not show up on scheduled meeting.

• Brand Name: ARROW
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): ARROW INTERNATIONAL, INC.; 2400 bernville road; reading PA 19605
• MDR Report Key: 7677029
• Report Number: 7677029
• Device Sequence Number: 10974978
• Product Code: LJS
• UDI-Device Identifier: 00801902095756
• UDI-Public: (01)00801902095756
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 06/29/2018
• Report Date (Section F): 06/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN033530
• Device Catalogue Number: PR-45541-HPHNM
• Device Lot Number: 13R17E0738
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/11/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2018
• 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
• Patient Weight: 60
• Date Report Sent to FDA: 06/29/2018