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

Catalog Number	CP-07511
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: during the procedure according to ifu, the end of the dilator was found to be bent so the wire could not enter.So md opened up the new kit to finish the procedure.The patient was reported as fine with no reported patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#1900111020.The report of a damaged dilator tip was confirmed through complaint investigation of the returned sample.The customer returned one, opened cath lab kit for analysis.The contents included one sheath/dilator assembly and one additional dilator for analysis.No obvious signs-of-use were observed on any of the returned components.Visual analysis revealed that the dilator (from returned sheath/dilator assembly) was defective at the tip.Microscopic examination confirmed that the dilator tip was split/deformed.No other defects or anomalies were observed.The damaged dilator length measured 6 13/16" via calibrated ruler, which was within the specification limits of 6 3/4"-7 1/4" per the dilator product drawing.The dilator outer diameter measured 0.0735" via calibrated caliper, which was within the specification limits of 0.071"-0.074" per the dilator extrusion product drawing.The dilator inner diameter (at the proximal end) measured 0.043" via calibrated pin gauge, which was within the specification limits of 0.043"-0.046" per the dilator extrusion product drawing.Functional inspection was performed per ifu statement, "ensure dilator hub fully snaps into sheath cap".The defective dilator was removed and reinserted through the returned sheath.Little to no resistance was encountered as the dilator passed completely through the sheath extrusion.The dilator hub was noted to lock into the sheath cap.A lab inventory guide wire with a diameter of 0.035" was inserted through the dilator tip.Despite the damage, the guide wire was able to pass with little to no difficulty.The ifu provided with the kit informs the user, "do not apply excessive force in removing guidewire or sheath/dilator.If withdrawal cannot be easily accomplished, determine cause using fluoroscopic guidance and request further consultation, if necessary".A device history record review was performed, and no relevant findings were identified.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: during the procdure according to ifu, the end of the dilator was found to be bent so the wire could not enter.So md opened up the new kit to finish the procedure.The patient was reported as fine with no reported patient harm or consequence.

• Brand Name: ARROW CATH LAB SHEATH INTRO SET
• Common Device Name: CATHETER PERCUTENEOUS
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18542718
• Report Number: 9680794-2024-00003
• Device Sequence Number: 18069515
• Product Code: DQY
• UDI-Device Identifier: 00801902002105
• UDI-Public: 00801902002105
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2023

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: CP-07511
• Device Lot Number: 14F23B0216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2023
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 02/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2023
• 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