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

Catalog Number	CL-07980
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "on (b)(6) 2024, the doctor found the sheath shim damaged and leaking during use on the patient." there was no medical intervention required.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "on (b)(6) 2024, the doctor found the sheath shim damaged and leaking during use on the patient." the operator changed to a different set.There was no medical intervention required.The patient's current condition is reported as "fine".
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 six findings were identified.Non-conformances were initiated for 14p23a0251 and 14p23a0030 to address the issue of "sheath valve leak in use".Despite these findings, without the sample returned for analysis, it cannot be determined if the failures addressed by these non-conformances are the same failure involved with this complaint.The instructions-for-use (ifu) provided with this kit warns the user, "do not suture directly to the outside diameter of the sheath to minimize the risk of cutting or damaging the sheath or impeding sheath flow".The ifu also states, "to minimize the risk of cutting the sheath, do not use scissors to remove the dressing".The ifu also states, " hemostasis valve must be occluded at all times to minimize the risk of air embolism or hemorrhage.If device introduction is delayed, or device is removed, temporarily cover valve opening with sterile-gloved finger until catheter or obturator is inserted.Use arrow obturator, either included with this product or sold separately, to occlude sheath.This will ensure that leakage does not occur and inner seal is protected from contamination".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.

• 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: 20459727
• Report Number: 9680794-2024-01028
• Device Sequence Number: 12953825
• Product Code: DQY
• UDI-Device Identifier: 00801902002082
• UDI-Public: (01)00801902002082(11)230921(17)280831(10)14F23J0013(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/20/2024

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 Catalogue Number: CL-07980
• Device Lot Number: 14F23J0013
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2023
• 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