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

Catalog Number	CL-07965
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that:"during the procedure according to ifu, the md found air is generated due to defective proximal hub." there was no reported patient harm or consequence.
Additional Manufacturer Narrative
Qn# (b)(4).The customer provided one photo for analysis.The photo shows a hemostasis body of a complaint of cath-lab sheath.No obvious defects/anomalies were observed.The customer also returned one, opened cath-lab kit for analysis.The cathlab assembly will be analyzed as part this complaint.No obvious signs-of-use were observed.Initial visual analysis revealed that the dilator was completely advanced into the cath-lab and the dilator hub was locked into the cap.The dilator was partially removed, and slight resistance was encountered, which resulted in the seal to eject from the proximal opening of the hemostasis cap.This is not the intended assembly of the seal.The seal was removed, and microscopic examination of the slits revealed that two of the three slits were torn at an angle.Between this and further dimensional analysis revealed that this tearing likely occurred due to the slits being below specification.No physical defects or anomalies were observed with any portion of the cath-lab, the dilator, nor the cap.Dimensional analysis was performed on one of the seal slits, which measured to be 0.0245", which is not within the specification limits of 0.035"-0.045" per the seal product drawing.Upon removal of the dilator from the cath-lab, minor resistance was observed.This resulted in the internal seal to completely exit through the cap of the hemostasis valve.Performed per ifu statement, "check lumen placement by holding sheath in place and withdrawing guidewire and dilator sufficiently to allow blood flow to be aspirated into side port.Flush and connect side port to appropriate line, as necessary".A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "hemostasis valve must be occluded at all times to minimize the risk of air embolism or hemorrhage.If device introduction is delayed, temporarily cover valve opening with sterile-gloved finger until 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".The customer complaint of a valve assembly separation was confirmed through complaint investigation.Visual analysis revealed that the internal seal exited the proximal opening of the hemostasis cap upon removal of the dilator, which is not the intended function.Further dimensional analysis revealed that the slits on the internal seal are not within specification.Based on the customer report and the sample received, the root cause is likely supplier related.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that: "during the procedure according to ifu, the md found air is generated due to defective proximal hub." there was no reported patient harm or consequence.

• 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: 20123558
• Report Number: 9680794-2024-00847
• Device Sequence Number: 7482519
• Product Code: DQY
• UDI-Device Identifier: 00801902002075
• UDI-Public: (01)00801902002075(11)240424(17)290331(10)14F24D0226(21)
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2024

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-07965
• Device Lot Number: 14F24D0226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2024
• 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