MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PSI KIT: 9 FR; INTRODUCER CATHETER

Model Number	IPN036826
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Customer reported "this product does not advance easily into the ij without having the dilator separate from the introducer".The user has to bend the spring wire guide around the dilator to keep both the wire and dilator in place.It was reported the dilator will dislodge from its place in the patient and a larger skin incision needs to be made.Surgicel is used to control bleeding at the insertion site.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The ifu provided with the kit informs the user, "do not withdraw dilator until the sheath is well within the vessel to reduce the risk of damage to sheath tip".The ifu also states, "dilator may be partially withdrawn to facilitate advancement of sheath through tortuous vessel".A device history record review was performed based on a potential lot from sales history, and no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.
Event or Problem Description
Customer reported "this product does not advance easily into the ij without having the dilator separate from the introducer".The user has to bend the spring wire guide around the dilator to keep both the wire and dilator in place.It was reported the dilator will dislodge from its place in the patient and a larger skin incision needs to be made.Surgicel is used to control bleeding at the insertion site.The patient's condition is reported as fine.

• Brand Name: ARROW PSI KIT: 9 FR
• Common Device Name: INTRODUCER CATHETER
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17164858
• Report Number: 9680794-2023-00433
• Device Sequence Number: 17581875
• Product Code: DYB
• UDI-Device Identifier: 10801902117516
• UDI-Public: 10801902117516
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K940079
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2023

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 Model Number: IPN036826
• Device Catalogue Number: AK-29903-CDC
• 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: 05/24/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: NOT REPORTED.; NOT REPORTED.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown