MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTI-LUMEN/PSI KIT 9 FR X 4-1/2" (11.5; CATHETER,INTRAVASCULAR,THERAP

Model Number	IPN037022
Medical Device Problem Codes	Material Separation (1562); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The mdr report key is (b)(4).The mdr text key is (b)(4).
Event or Problem Description
Complaint found in maude database reports: "patient with a pre-operative diagnosis including severe aortic stenosis, prior liver transplant and femoral-femoral bypass was admitted to the operating room for placement of a central line (arrowg+ard blue mac two-lumen central venous access).Surgeon felt guidewire resistance and had to manipulate the wire to get it out.Upon inspection of the guidewire, doctor suspected a piece broke off inside the patient.Doctor placed a new line and clinical staff continued with the planned procedure.After the procedure was finished, clinical staff looked with ultrasound and x-ray and determined a part of the wire was retained inside the patient.Doctors scrubbed in to search for the part of the wire.The surgery was prolonged about 3 hours.The piece was found, taken out and sent to pathology.".
Event or Problem Description
Complaint found in maude database reports: "patient with a pre-operative diagnosis including severe aortic stenosis, prior liver transplant and femoral-femoral bypass was admitted to the operating room for placement of a central line (arrowg+ard blue mac two-lumen central venous access).Surgeon felt guidewire resistance and had to manipulate the wire to get it out.Upon inspection of the guidewire, doctor suspected a piece broke off inside the patient.Doctor placed a new line and clinical staff continued with the planned procedure.After the procedure was finished, clinical staff looked with ultrasound and x-ray and determined a part of the wire was retained inside the patient.Doctors scrubbed in to search for the part of the wire.The surgery was prolonged about 3 hours.The piece was found, taken out and sent to pathology.".
Additional Manufacturer Narrative
(b)(4).The mdr report key is (b)(4).The mdr text key is (b)(4).284980160.Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW MULTI-LUMEN/PSI KIT 9 FR X 4-1/2" (11.5
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 14058257
• Report Number: 9680794-2022-00222
• Device Sequence Number: 14607800
• Product Code: FOZ
• UDI-Device Identifier: 10801902118407
• UDI-Public: 10801902118407
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K011761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: IPN037022
• Device Catalogue Number: ASK-21242-IMC
• Device Lot Number: 13F21G0099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2022
• Supplement Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 04/08/2022
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown