MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CV-47702-E
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: (b)(6) 2023, the doctor found that the swg was kinked prior to use on the patient.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer report of a kinked guide wire was confirmed through examination of the returned sample.Visual analysis revealed multiple kinks along the guide wire body.Despite this, the guide wire passed all relevant dimensional and functional requirements, and a device history record review revealed no relevant findings.During normal assembly, the kinked portions of the guidewire are protected within the protective tubing of the advancer assembly, however, the end cap was missing from the assembly and not returned.Based on the customer report and sample received, the potential root cause cannot be determined as it cannot be confirmed when the damage occurred.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that: (b)(6) 2023, the doctor found that the swg was kinked prior to use on the patient.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Udi related data quality updates only.Section d.4.-(udi)# corrected to (b)(4).The customer report of a kinked guide wire was confirmed through examination of the returned sample.Visual analysis revealed multiple kinks along the guide wire body.Despite this, the guide wire passed all relevant dimensional and functional requirements, and a device history record review revealed no relevant findings.During normal assembly, the kinked portions of the guidewire are protected within the protective tubing of the advancer assembly, however, the end cap was missing from the assembly and not returned.Based on the customer report and sample received, the potential root cause cannot be determined as it cannot be confirmed when the damage occurred.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that: 19 sep 2023, the doctor found that the swg was kinked prior to use on the patient.There was no patient involvement.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18072540
• Report Number: 3006425876-2023-01038
• Device Sequence Number: 7815632
• Product Code: FOZ
• UDI-Device Identifier: 10801902102536
• UDI-Public: (01)10801902102536(11)220908(17)240627(10)71F22J0226(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K993691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2023

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: Health Professional
• Device Expiration Date: 06/27/2024
• Device Catalogue Number: CV-47702-E
• Device Lot Number: 71F22J0226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 11/22/2023; Not provided
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 11/22/2023; 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2022
• 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; NOT REPORTED
• Patient Sex: Unknown