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

Model Number	IPN000137
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	05/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Udi number: (b)(4).
Event or Problem Description
It was reported " catheter did not fit trough the sheath.Catheter got stuck, tips looks pushed together.Proceeding procedure was harder, since they could not use 6fr material".The device was removed and replaced.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported " catheter did not fit trough the sheath.Catheter got stuck; tips looks pushed together.Proceeding procedure was harder, since they could not use 6fr material".The device was removed and replaced.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).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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported " catheter did not fit trough the sheath.Catheter got stuck, tips looks pushed together.Proceeding procedure was harder, since they could not use 6fr material".The device was removed and replaced.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one, opened psi kit for analysis.Signs-of-use were observed on the sheath surface and inside the sidearm.It was noted that the sheath and lidstock were returned severely folded inside the packaging.This resulted in slight bending to form on the sheath body; however, nothing severe enough to be considered a kink.It is being assumed that this bending occurred while in transit to the (b)(6) facility.No other defects or anomalies were observed on the opened sample.Likewise, no defects or anomalies were observed on the representative sample.The sheath length measured 17 5/8", which is within the specification of the sheath product drawing.The sheath inner diameter at the distal tip measured outer diameter measured 0.085", which is within the specification of the sheath product drawing.The sheath outer diameter measured 0.114", which is within the specification of the wrapped extrusion product drawing.The 6fr dilator from the representative sample was inserted through the sheath involved with this complaint.Little to no resistance was observed as the dilator passed completely through the sheath and locked into the hemostasis cap.Performed per ifu statement, "ensure dilator hub fully snaps into sheath cap".The sheath product drawing and the wrapped extrusion product drawing were reviewed as part of this complaint investigation.The ifu provided with the kit informs the user, "do not withdraw dilator until sheath is well within vessel to minimize the risk of sheath tip damage".The report of a catheter tight in sheath was not able to be confirmed through complaint investigation of the returned sample.Visual analysis did not reveal any defects or anomalies on the returned sample.Likewise, the sample met all relevant dimensional and functional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, no problem was found with the returned device.Teleflex will continue to monitor and trend for reports of this nature.

• 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19553776
• Report Number: 9680794-2024-00601
• Device Sequence Number: 15131221
• Product Code: DQY
• UDI-Device Identifier: 00801902001856
• UDI-Public: (01)00801902001856(11)210714(17)260630(10)14F21F0588(21)
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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,Followup
• Report Date (Section B): 05/27/2024

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: 06/30/2026
• Device Model Number: IPN000137
• Device Catalogue Number: CL-07645
• Device Lot Number: 14F21F0588
• 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: 05/27/2024
• Supplement Date Received by Manufacturer: 07/16/2024; 08/13/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 07/24/2024; 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2021
• 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; NONE REPORTED
• Patient Sex: Unknown