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

Model Number	IPN920377
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that "when the anaesthetist tried to pull the inlay (dilator) out of the sheath after inserting it into the vessel, the cone of the dilator broke off quite smoothly and the dilator remained inside the sheath.Fortunately, the dilator did not slide further into the vessel, so we were able to retrieve it together with the sheath.Afterwards, we laid a new sheath of this type.There were no incidents there.Unfortunately, the product in question was accidentally discarded and is not available for further investigations." the patient's condition is reported as fine.
Event or Problem Description
It was reported that "when the anaesthetist tried to pull the inlay (dilator) out of the sheath after inserting it into the vessel, the cone of the dilator broke off quite smoothly and the dilator remained inside the sheath.Fortunately, the dilator did not slide further into the vessel, so we were able to retrieve it together with the sheath.Afterwards, we laid a new sheath of this type.There were no incidents there.Unfortunately, the product in question was accidentally discarded and is not available for further investigations." the patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided three photos for analysis.The complaint of dilator hub separated was able to be confirmed by the photos.The first and second photos revealed that the hub was completely separated from the proximal end of the dilator.The third photo showed the lidstock information.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instruction label provided with this kit warns the user, "warning: 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.Warning: do not cut sheath to alter length.Ensure dilator hub fully snaps into sheath cap." without the device to evaluate, 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: 16598668
• Report Number: 9680794-2023-00193
• Device Sequence Number: 12156858
• Product Code: DQY
• UDI-Device Identifier: 10801902194197
• UDI-Public: 10801902194197
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2023

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
• Device Model Number: IPN920377
• Device Catalogue Number: CP-07911
• Device Lot Number: 14F22G0013
• 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: 02/24/2023
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2022
• 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