MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 4 FR X 13 CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN030137
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
The physician tried to insert the spring wire guide into the patient, but the physician felt it was bent.It was hard to enter into patient's vessel.A new device was obtained for use and procedure completed.No patient harm reported.The patient's condition is reported as fine.
Event or Problem Description
The physician tried to insert the spring wire guide into the patient, but the physician felt it was bent.It was hard to enter into patient's vessel.A new device was obtained for use and procedure completed.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire assembly for analysis.No definite signs-of-use were observed.Visual analysis revealed one major kink on the guide wire body.This kink resulted in the distal j-bend to be deformed.No other defects or anomalies were observed.The kink on the guide wire measured 29mm from the distal tip.The guide wire length measured 45.1cm, which is within the specification limits of 44.4cm-45.6cm per the guide wire graphic.The guide wire outer diameter measured.446mm, which is within the specification limits of.430mm-.470mm per the guide wire graphic.The guide wire was inserted through a lab inventory introducer needle.Little to no resistance was observed.Performed per ifu statement, "raise thumb and pull arrow advancer approximately 4-8 cm away from arrow raulerson syringe or introducer needle.Lower thumb onto arrow advancer and while maintaining a firm grip on guidewire, push assembly into syringe barrel to further advance guidewire.Continue until guidewire reaches desired depth".A manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested." the report of a kinked guide wire was confirmed through complaint investigation.Visual analysis revealed one major kink on the guide wire.The guide wire met all relevant dimensional and functional requirements , and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 13 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11755510
• Report Number: 9680794-2021-00183
• Device Sequence Number: 4138050
• Product Code: FOZ
• UDI-Device Identifier: 10801902097191
• UDI-Public: 10801902097191
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2021

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: No Information
• Device Expiration Date: 04/30/2021
• Device Model Number: IPN030137
• Device Catalogue Number: CS-24402
• Device Lot Number: 14F19F0238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Initial Date Received by Manufacturer: 04/12/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1