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

Model Number	IPN920043
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "sheath was inserted.Attempt to advance a jl 6 guiding catheter failed, strong resistance was felt.Sheath and catheter were removed and a new sheath of the same lot was inserted.The same problem occurred, again the catheter could not be advanced.User changed to a terumo sheath which was successful." no patient harm reported.The patient's condition is reported as fine.It was reported the guide catheters that are inserted into the sheath have curved tips.When inserting the catheter through the sheath, resistance is felt near the tip of the sheath.The sheath seems to tighten in the inner lumen at the tip.
Event or Problem Description
It was reported that "sheath was inserted.Attempt to advance a jl 6 guiding catheter failed, strong resistance was felt.Sheath and catheter were removed and a new sheath of the same lot was inserted.The same problem occurred, again the catheter could not be advanced.User changed to a terumo sheath which was successful." no patient harm reported.The patient's condition is reported as fine.It was reported the guide catheters that are inserted into the sheath have curved tips.When inserting the catheter through the sheath, resistance is felt near the tip of the sheath.The sheath seems to tighten in the inner lumen at the tip.
Additional Manufacturer Narrative
Qn# (b)(4).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 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.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 15127102
• Report Number: 9680794-2022-00490
• Device Sequence Number: 6626053
• Product Code: DQY
• UDI-Device Identifier: 10801902192445
• UDI-Public: 10801902192445
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2022

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 Model Number: IPN920043
• Device Catalogue Number: CL-07645
• Device Lot Number: 14F21K0202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2022
• Supplement Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2021
• 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: VSI CATHETER, CATALOG# 5571; VSI CATHETER, CATALOG# 5571
• Patient Sex: Unknown