MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PI MIDLINE 1-L: 4.5FR X 15CM; MIDLINE CATHETER

Catalog Number	CDC-41541-MPKC
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the sheath kinked and rolled back at the transition during the procedure and a replacement kit was needed to complete the procedure.The user reported "the dilator tip entered the skin but the sheath would not enter the skin despite holding it close to the arm and using rotation while advancing.As i applied increased pressure, the sheath pushed up/buckled/kinked." the patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer report of a damaged sheath tip was confirmed by complaint investigation of the returned sample.The customer provided two images for evaluation; the distal tip of the peel away sheath was observed to be folded over.The customer returned one peel away sheath and dilator for analysis.Definite signs of use were observed.Visual examination of the sheath assembly revealed the sheath tip was slightly crushed and folded over.The middle of the sheath body also appeared to be slightly folded.Slight bending of the dilator body towards the distal end was also observed.All the damage was consistent with force being applied to the distal tip of the device.After conducting dimensional analysis, the sheath body was cross-sectioned to analyse the grooves from the peel-away lines.The outer diameter of the sheath body measured 0.08110" via calibrated micrometer which was within specifications of 0.078 -0.0 84" per product drawing.Functional inspection was performed per ifu statement "ensure dilator is in position and locked to hub of sheath.Thread peel-away sheath/dilator assembly over guidewire.".The dilator was inserted into the sheath and was able to lock into the hub of the sheath.A lab inventory guide wire was also able to be threaded through the subassembly with little to no issues.Manufacturing unit indicated that during the manufacturing process there was a 100% inspection for tips and the results of the re-inspection of the material available in inventory at the plant were satisfactory, with zero defective pieces found for the failure mode reported by the customer.The ifu provided with this kit informs the user, "do not use excessive force when introducing guidewire, peel-away sheath over tissue dilator, or tissue dilator as this can lead to vessel perforation and bleeding, or component damage." the ifu also cautions the user "do not withdraw dilator until sheath is well within vessel to reduce risk of damage to sheath tip".A device history record review was performed, and no relevant findings to this complaint event were identified.Based on the customer report that the damage was observed during use, the appearance of the damage, and the manufacturing evaluation, the root cause could not be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported the sheath kinked and rolled back at the transition during the procedure and a replacement kit was needed to complete the procedure.The user reported "the dilator tip entered the skin but the sheath would not enter the skin despite holding it close to the arm and using rotation while advancing.As i applied increased pressure, the sheath pushed up/buckled/kinked." the patient's condition is reported as fine.

• Brand Name: ARROW AGBA PI MIDLINE 1-L: 4.5FR X 15CM
• Common Device Name: MIDLINE CATHETER
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17855822
• Report Number: 9680794-2023-00728
• Device Sequence Number: 15143354
• Product Code: PND
• UDI-Device Identifier: 10801902205435
• UDI-Public: 10801902205435
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K161313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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 Expiration Date: 12/31/2024
• Device Catalogue Number: CDC-41541-MPKC
• Device Lot Number: 33F23D0743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2023
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown