MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CATH-LAB SHEATH INTRO SET; CATHETER PERCUTANEOUS

Catalog Number	CP-07911
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).Udi number: (b)(4).
Event or Problem Description
It was reported, "prior to the procedure according to ifu, the md discovered that the tip of the dilator is sharp.So, they determined that it was unfit to be used.They opened up a new product to complete the procedure." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one, opened cath-lab kit for analysis.Signs-of-use in the form of biological material were observed inside the dilator body.It was also noted that the dilator was inserted through the valve end of the cath-lab.Visual analysis revealed that the dilator tip was severely split/frayed.Microscopic examination confirmed the damage and revealed white stress marks.The dilator length from the hub to the distal tip measured 6 7/8", which is within the specification limits of 6 3/4"-7 1/4" per the dilator product drawing.The dilator outer diameter measured 0.124", which is within the specification limits of 0.123"-0.126" per the dilator extrusion product drawing.The dilator inner diameter at the proximal end measured 0.044", which is within the specification limits of 0.043"-0.046" per the dilator extrusion product drawing.The inner diameter at the distal tip could not be accurately measured due to the severity of the damage.The returned dilator was able to be removed and re-inserted into the valve end of the returned cath-lab.Little to no resistance was encountered as the dilator passed completely through the sheath.The dilator hub was able to snap into the valve cap.Performed per ifu statement, "ensure dilator hub fully snaps into sheath cap".A lab inventory 9fr dilator was inserted through the valve end of the cath-lab.Little to no resistance was observed as the dilator advanced completely through the cath-lab.Likewise, no damage was observed on the lab inventory dilator tip after insertion.R & d have confirmed they do not have a root cause for this failure at this time.A device history record review was performed, and no relevant findings were identified.The report of a damaged dilator tip was confirmed through complaint investigation.Visual analysis revealed that the dilator tip was split/frayed.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 has not been determined at this time.Non-conformance was initiated so that the manufacturing facility can further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "prior to the procedure according to ifu, the md discovered that the tip of the dilator is sharp.So, they determined that it was unfit to be used.They opened up a new product to complete the procedure." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine.".

• Brand Name: ARROW CATH-LAB SHEATH INTRO SET
• Common Device Name: CATHETER PERCUTANEOUS
• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19730758
• Report Number: 9680794-2024-00700
• Device Sequence Number: 8274518
• Product Code: DQY
• UDI-Device Identifier: 00801902002167
• UDI-Public: (01)00801902002167(11)210405(17)260331(10)14F21C0266(21)
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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

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: 03/31/2026
• Device Catalogue Number: CP-07911
• Device Lot Number: 14F21C0266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/23/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2021
• 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