MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PSI KIT: 8.5 FR; INTRODUCER CATHETER

Catalog Number	CA-09886
Medical Device Problem Codes	Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported " difficulties with inserting bioptome through cordis due to sticking and not smooth.Squeaking noise noted during bioptome insertion.Doctor felt resistance with feeding the bioptome through the introducer as well as resistance with feeing the wire into the sheath." 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)(6) complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and a potential finding was identified.As no sample was returned for investigation, it could not be determined if the finding was relevant.The ifu provided with the kit informs the user , "insert entire length of dilator through hemostasis valve into sheath pressing hub of dilator firmly into hub of hemostasis valve/side port assembly.Place assembly on sterile field awaiting final sheath placement." the ifu also states, "do not apply excessive force in removing guide wire, dilator or sheath.If withdrawal cannot be easily accomplished, a chest x-ray should be obtained and further consultation requested".The lidstock artwork indicates that the sheath involved with this kit should be used in tandem with 7-7.5 fr catheters.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.
Event or Problem Description
It was reported " difficulties with inserting bioptome through cordis due to sticking and not smooth.Squeaking noise noted during bioptome insertion.Doctor felt resistance with feeding the bioptome through the introducer as well as resistance with feeing the wire into the sheath." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW PSI KIT: 8.5 FR
• 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: 19861698
• Report Number: 9680794-2024-00723
• Device Sequence Number: 15479374
• Product Code: DYB
• UDI-Device Identifier: 10801902001303
• UDI-Public: (01)10801902001303(11)200508(17)241231(10)13F20E0159(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K780532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2024

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 Expiration Date: 12/31/2024
• Device Catalogue Number: CA-09886
• Device Lot Number: 13F20E0159
• 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: 07/04/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2020
• 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 REPPORTED
• Patient Sex: Unknown