MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Model Number	IPN920475
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during the insertion of the dilator, they encountered resistance to introduction.As they pulled out the entire device, they noticed that the guide-wire was bent in several point." no patient harm was reported.A new guidewire was used.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "during the insertion of the dilator, they encountered resistance to introduction.As they pulled out the entire device, they noticed that the guide-wire was bent in several point." no patient harm was reported.A new guidewire was used.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one guide wire and all four of the dilator types provided within the kit (16fr safe sheath d-pro, tunneler dilator, 12fr dilator, and 14fr dilator).Signs of use in the form of biological material was observed on the safe sheath d-pro dilator.Visual analysis revealed that the guide wire was severely kink bent in several locations.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were secure and intact.No defects or anomalies were observed with any of the returned dilators.The major kinks in the guide wire measured 271mm, 373mm, 483, 525mm, and 622mm from the proximal weld.The guide wire total length measured approximately 100.5cm, which is within the specification limits of 98.75mm-101.25mm per the guide wire product drawing.The guide wire outer diameter measured.0370", which is within the specification limits of.0370"-.0385" per the guide wire product drawing.The 14fr dilator outer diameter measured.185", which equals the nominal value of.185" per the dilator product drawing.The 14fr dilator inner diameter at the distal tip measured.041", which is within the specification limits of.040"-.042" per the dilator product drawing.The 12fr dilator outer diameter measured.158", which equals the nominal value of.158" per the dilator product drawing.The 12fr dilator inner diameter at the distal tip measured.041", which is within the specification limits of.040"-.042" per the dilator product drawing.The dilator from the safe sheath d-pro assembly outer diameter.212", which is within the specification limits of.209"-.212" per the safe sheath d-pro product drawing.The dilator inner diameter at the distal tip measured.038", which is within the specification limits of.038"-.039" per the safe sheath d-pro product drawing.The tunneling dilator outer diameter measured.2745", which is within the specification limits of.2720"-.2780" per the tunneling dilator product drawing.The dilator inner diameter at the distal tip measured.130" , which equals the nominal value of.130" per the tunneling dilator product drawing.The guide wire was inserted through the 14fr, 12fr, and 16fr safe sheath d-pro dilators.Minor resistance was encountered at the locations of the kinking; however, the guide wire was able to pass through all dilators.No resistance was encountered in areas not affected by kinking.Performed per ifu statement, "carefully place 12 fr.Tissue dilator onto guidewire and advance to appropriate depth.A twisting motion may assist in advancing through tissue.Repeat this procedure using 14 fr tissue dilator.Thread dilator/sheath assembly over guidewire".The tunneling dilator is not meant to pass over the guide wire, but instead the catheter.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 informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The ifu also states, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The report of a kinked guide wire was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the guide wire was kinked in multiple locations across the body.Functional evaluation of the dilators revealed that the unkinked portions of the guide wire were able to pass as expected, however, slight resistance was met while advancing the kinked portions.The guide wire and the dilators met all relevant dimensional requirements, and a device history record review was performed with no relevant findings.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM RETR
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• 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: 15973524
• Report Number: 9680794-2022-00775
• Device Sequence Number: 6151022
• Product Code: MSD
• UDI-Device Identifier: 30801902195136
• UDI-Public: 10801902195132
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2022

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: 04/30/2025
• Device Model Number: IPN920475
• Device Catalogue Number: CS-15232-VFE
• Device Lot Number: 13F22F0595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 12/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2022
• 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
• Patient Sex: Unknown