MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-15703
Medical Device Problem Codes	Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: "the problem is the metal guidewire, which bends several times after being inserted into the central catheter and destroys the catheter.We cannot withdraw it until after the catheter is withdrawn and it ruptures." there was no reported patient harm or consequence.Associated complaints 3006425876-2024-00575 and 3006425876-2024-00576.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed, and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Corrected data: udi number unavailable as complainant did not report a lot number.
Event or Problem Description
It was reported that: "the problem is the metal guidewire, which bends several times after being inserted into the central catheter and destroys the catheter.We cannot withdraw it until after the catheter is withdrawn and it ruptures." there was no reported patient harm or consequence.Associated complaints 3006425876-2024-00576.
Event or Problem Description
It was reported that: "the problem is the metal guidewire, which bends several times after being inserted into the central catheter and destroys the catheter.We cannot withdraw it until after the catheter is withdrawn and it ruptures." there was no reported patient harm or consequence.Associated complaints 3006425876-2024-00575 and 3006425876-2024-00576.
Additional Manufacturer Narrative
(b)(4).Update to investigation is as follows: the customer provided one photo for analysis.The photo showed two, unopened kits.As the instance involved with this complaint occurred during use, it is being assumed that the pictured kits are representative samples.The complaint of guide wire/catheter resistance was not able to be confirmed by the photo.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "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 customer report of an unraveled guide wire due to catheter resistance was not confirmed by visual inspection of the customer supplied photo.However, full complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Corrected data:.

• Brand Name: CVC SET: 3-LUMEN 7 FR X 20 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: 19496642
• Report Number: 3006425876-2024-00575
• Device Sequence Number: 17807770
• Product Code: DQY
• UDI-Device Identifier: 30801902125959
• UDI-Public: 30801902125959
• Combination Product (Y/N): N
• PMA/510(K) Number: K862056
• 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,Followup
• Report Date (Section B): 05/13/2024

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-15703
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 06/28/2024; 07/02/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 07/01/2024; 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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