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

Model Number	IPN000124
Medical Device Problem Code	Difficult to Flush (1251)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The sheath could not be flushed prior to patient use.No patient involvement reported.
Additional Manufacturer Narrative
(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
The sheath could not be flushed prior to patient use.No patient involvement reported.
Additional Manufacturer Narrative
(b)(4).The customer returned multiple components of a psi kit, including the sheath assembly, dilator, obturator , and product lidstock.After meeting resistance during functional testing, visual examination revealed fogginess due to material buildup in the intersection of the side arm and stopcock.The material was tested via ftir analysis, and it was determined to be polycarbonate.No other defects or anomalies were observed.The outer diameter of the sheath measured 0.166" which is within the specification limits of 0.163"-0.167" per sheath extrusion graphic.The outer diameter of the side arm measured 0.132" which is within the specification limits of 0.130"-0.134" per side arm extrusion graphic.The instructions-for-use (ifu) provided with the kit informs the user, "prepare sheath for insertion by flushing through side arm." the returned sheath was flushed with water to functionally test the sheath.The sheath initially met significant resistance when trying to flush through the stopcock in the side arm.The side arm was then removed and flushed again, and it continued to meet significant resistance.A buildup of material was observed at the junction between the stopcock and sidearm.A lab inventory guide wire was used to break down the material, and then the sheath flushed as intended.Manufacturing was contacted to further analyze the sample.Manufacturing stated that they cannot assure that it is a manufacturing issue.They stated that the valve is 100% inspected with a blowoff test after gluing is dried.For this test, the air should flow freely through the extension line.If it does not flow freely, it is because the valve is clogged, and part is rejected.Further, when this part is completely assembled with the rest of components, a 100% inspection is carried out of vacuum test.In this same test, the piece is inspected at the end for contamination, scratches, imperfections, or cracks in the piece.Additionally, polycarbonate is not used in their manufacturing process.A device history record review was performed and no relevant manufacturing issues were identified.The ifu provided with this kit cautions the user, "some disinfectants used at the sheath insertion site contain solvents, which can attack the sheath material.Assure insertion site is dry before dressing." the ifu also states, "alcohol and acetone can weaken the structure of polyurethane materials.Check ingredients of prep sprays and swabs for acetone and alcohol content." the report of a blocked sheath was confirmed based on the complaint investigation.Visual examination revealed a fogginess at the intersection of the stopcock and sidearm.The fogginess was revealed to be caused by buildup of polycarbonate.The sheath passed all dimensional and functional testing after removing the polycarbonate, and a device history record review was performed with no relevant findings.Manufacturing confirmed that the parts are 100% inspected and polycarbonate isn't used in the manufacturing process.Based on the customer report and investigation findings, the root cause cannot be determined.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
The sheath could not be flushed during patient use.No patient injury reported.

• Brand Name: ARROW CATH-LAB SHEATH INTRO SET
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 11787317
• Report Number: 9680794-2021-00211
• Device Sequence Number: 3869143
• Product Code: DQY
• UDI-Device Identifier: 00801902001689
• UDI-Public: 00801902001689
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 04/19/2021

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 Expiration Date: 12/31/2025
• Device Model Number: IPN000124
• Device Catalogue Number: CL-07024
• Device Lot Number: 14F21A0126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 06/04/2021; 07/22/2022
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 06/04/2021; 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2021
• 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
• Patient Sex: Unknown