MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MAC KIT: 2-L 9 FR DISTAL X 11.5 CM; INTRODUCER CATHETER

Catalog Number	CDC-11242-1A
Medical Device Problem Codes	Inflation Problem (1310); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the latex free balloon nearly always sustains damage after being passed through the mac into the patient.They notice that there is a problem when they try to inflate the balloon and there is no resistance.When they remove the swan they can see that the balloon has been compromised.At some point during passage through the mac the damage is occurring.Another device is used to resolve the issue." associated complaints:.9680794-2025-00063, 9680794-2025-00064 and 9680794-2025-00065.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer provided one image showing the box and lidstock of the edwards swan-ganz catheter.The multi-lumen access catheter (mac) involved with this complaint was not pictured.The customer also returned one 7fr latex-free swan-ganz catheter for analysis.Swan-ganz is not a teleflex product; however, it is used in tandem with the multi-lumen access catheter (mac).A note was also returned that indicates this swan-ganz is not the damaged catheter involved with this complaint.The catheter was provided as a representative sample.The mac associated with the complaint was not returned.Visual analysis did not reveal any obvious signs of use on the returned swan-ganz.Likewise, no defects or anomalies were observed.The outer diameter of the returned swan-ganz catheter from the tip to the 40cm marking measured 0.0875".This equates to 6.67 french.A lab inventory mac (2-lumen 9fr x 11.5cm) was obtained.The returned swan-ganz was inserted through the mac.No resistance was encountered.Once fully inserted, a lab inventory syringe was attached to the swan-ganz.The balloon at the distal end was inflated.The balloon was then deflated and retracted back through the mac.No resistance was encountered.Once fully removed, further visual and functional analysis of the balloon on the swan-ganz revealed that it was still functional and did not sustain damage.Performed per ifu statement, "feed catheter through access device assembly into vessel.Advance catheter to desired position".A device history record review was performed, and a finding was identified; however, it was determined that the finding was not relevant to the complaint.The lidstock indicates "mac two-lumen central venous access for use with 7.5 - 8 fr.Catheters".The ifu provided with the kit informs the user, "do not inflate balloon prior to insertion through catheter contamination shield to minimize the risk of balloon damage".The ifu also states, "if flow directed catheter is used, inflate and deflate balloon with syringe to ensure integrity.Precaution: do not exceed balloon catheter manufacturer's recommended volume".The customer report of a sheath tight over a non-arrow catheter could not be determined through complaint investigation of the returned sample.A 7fr, latex-free swan-ganz was returned as a representative sample.The actual mac involved with this complaint was not returned.Therefore, a full visual, dimensional, or functional analysis could not be performed without the mac also returned.Based on the testing of the returned representative sample and without the teleflex mac returned for evaluation, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "the latex free balloon nearly always sustains damage after being passed through the mac into the patient.They notice that there is a problem when they try to inflate the balloon and there is no resistance.When they remove the swan they can see that the balloon has been compromised.At some point during passage through the mac the damage is occurring.Another device is used to resolve the issue." associated complaints: 9680794-2025-00062, 9680794-2025-00063, 9680794-2025-00064 and 9680794-2025-00065.

• Brand Name: ARROW MAC KIT: 2-L 9 FR DISTAL X 11.5 CM
• Common Device Name: INTRODUCER CATHETER
• 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: 21136622
• Report Number: 9680794-2025-00062
• Device Sequence Number: 13828169
• Product Code: FOZ
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K002507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: CDC-11242-1A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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