MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-12122-E
Medical Device Problem Codes	Difficult to Insert (1316); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "the user felt it difficult to insert the dilator into the patient during the procedure.Therefore, another dilator from a new kit was used instead to complete the procedure.No injury to the patient was reported." there was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the user felt it difficult to insert the dilator into the patient during the procedure.Therefore, another dilator from a new kit was used instead to complete the procedure.No injury to the patient was reported." there was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one dilator for analysis.Signs of use were observed inside the dilator body.Visual and microscopic examination revealed that the dilator tip was split/folded.White stress marks are also visible.No other defects or anomalies were observed.The dilator length measured 5 3/8", which is within the specification limits of 5 1/4"-5 3/4" per the dilator product drawing.The dilator inner diameter at the distal tip measured 0.037", which is within the specification limits of 0.036"-0.038" per the dilator product drawing.The dilator outer diameter at the smaller portion of the extrusion measured 0.1295", which is within the specification limits of 0.1250"-0.1370" per the dilator product drawing.The outer diameter at the larger portion of the extrusion measured 4.00mm, which is within the specification limits of 3.97mm-4.06mm per the dilator extrusion product drawing.A lab inventory guide wire (measured 0.034") was inserted through the returned dilator.Despite the damage to the dilator tip, the guide wire was able to pass.Minor resistance was encountered from within the extrusion.This was due to congealed biological material.Once removed, the guide wire passed with little to no difficulty.Performed per ifu statement, "use tissue dilator to enlarge tissue tract to the vein as required.Follow the angle of the guidewire slowly through the skin".R & d and manufacturing have been consulted regarding investigations of this nature.They stated that various factors could contribute to the observed damage to the dilator tip, including the manufacturing process and/or undue force applied unintentionally by the user.Due to the possibility that manufacturing contributed to this damage, they will further investigate this issue.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 report of a damaged dilator tip was confirmed through complaint investigation.Visual analysis revealed that the dilator tip was frayed and folded.Despite the damage, all relevant dimensional and functional requirements were met, and a device history record review did not reveal any relevant findings.Based on the customer report, the sample received, and the comments from r & d, the root cause cannot be determined.A non-conformance was initiated so the manufacturing facility could further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM
• Common Device Name: CATHETER PERCUTANEOUS
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20367457
• Report Number: 3006425876-2024-01028
• Device Sequence Number: 12479922
• Product Code: DQY
• UDI-Device Identifier: 20801902096191
• UDI-Public: (01)20801902096191(11)221222(17)271130(10)71F22M1800(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2024

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
• Device Catalogue Number: CS-12122-E
• Device Lot Number: 71F22M1800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2022
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown