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

Catalog Number	CL-07624
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "during the procedure according to ifu, the md found the catheter distal tip to be bent.So the md opend up the new kit to finish the procedure." the device was removed and replaced.No delay to therapy.No patient harm or injury.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one, opened cath-lab sheath set including the sheath extension assembly for analysis.The dilator was not returned.Signs of use in the form of biological material were observed on and within the distal tip of the sheath extrusion.Visual analysis revealed that the distal tip of the cath-lab sheath appeared bent.The damage observed is consistent with undue force being applied during insertion.Microscopic examination confirmed the damage.The inner diameter of the sheath at the distal tip measured 0.083" which is not within the specification limits of 0.085"-0.087" per sheath ext assy w/ dilator product drawing.The length of the sheath from the distal end of the hemostasis valve to the distal tip measured 9 3/4" which is within specification limits of 8 7/8"-9 3/4" per sheath ext assy w/ dilator product drawing.The outer diameter of the sheath measured 0.115" which is within the specification limits of 0.111"-0.115" per sheath ext assy w/ dilator product drawing.The sheath was functionally tested per the product instructions-for-use (ifu).The ifu provided with this kit instructs the user, "ensure dilator hub fully snaps into sheath cap." a lab inventory 6 fr dilator was inserted through the hemostasis valve cap.Resistance was met as the dilator advanced through the proximal end of the sheath.Excess biological material was pushed out of the sheath.Once the biological material was cleared, the dilator and was able to advance through with little to no resistance, and the dilator hub was able to snap into the sheath cap as intended.The distal end of the sheath was wiped with an alcohol wipe to confirm the discoloration was due to biological material and not signs of burning from the heat-treating process.The discoloration was able to be removed with an alcohol wipe confirming the biological material.Manufacturing and r & d were contacted as a part of this complaint investigation.R & d suggests that the discrepancy in the sheath tip inner diameter and the bend may be due to the trimming process during manufacturing.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit warns the user, "do not apply excessive force in removing guidewire or sheath/dilator.Do not withdraw dilator until sheath is well within vessel to minimize the risk of sheath tip damage.Dilator may be partially withdrawn to facilitate advancement of sheath through tortuous vessel." the customer report of a bent sheath tip was confirmed by complaint investigation of the returned sample.The sample passed all relevant functional requirements, however, the distal tip of the sheath extrusion measured lower than the specification limits.It is possible for the smaller diameter of the sheath tip to encounter resistance during insertion which could result in the damage observed on the returned sample.In addition, comments from r & d suggest the discrepancy in the sheath tip inner diameter may be due to the trimming process during manufacturing.Based on these circumstances, manufacturing caused or contributed to the observed defect.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported "during the procedure according to ifu, the md found the catheter distal tip to be bent.So the md opend up the new kit to finish the procedure." the device was removed and replaced.No delay to therapy.No patient harm or injury.The patient's current condition is reported as "fine".

• 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: 19164463
• Report Number: 9680794-2024-00354
• Device Sequence Number: 15417821
• Product Code: DQY
• UDI-Device Identifier: 00801902001825
• UDI-Public: 00801902001825
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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
• Report Date (Section B): 03/27/2024

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
• Device Catalogue Number: CL-07624
• Device Lot Number: 14F23E0111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2023
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown