MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC NAVICURVE: 2L 5.5FR X 55CM BP; CATHETER, INTRAVASCULAR, THERA

Catalog Number	DLX-45552-CURVB
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "dilator kinked back on itself." the device was removed and a new peelaway sheeth/dilator was used.No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported "dilator kinked back on itself." the device was removed and a new peelaway sheeth/dilator was used.No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer report of a damaged sheath was confirmed by complaint investigation of the returned sample.The customer returned one p eel-away sheath and dilator for analysis.Definite signs-of-use were observed.Visual examination revealed that the distal tip of the sheath appeared folded inwards.Additionally, the sheath body was slightly damaged.The damage on the sheath measured approximately 55mm via calibrated ruler from the tabs.The total length of the sheath body measured to be 2 3/4" via calibrated ruler, which was within the specifications of 2 5/8" - 2 7/8" per product drawing.The outer diameter (od) of the sheath measured 0.09825" via calibrated micrometer which was within the specification limits of 0.096" - 0.102" per the sheath extrusion drawing.The inner diameter (id) of the sheath at the distal tip measured 0.078" via calibrated pin gauge which was within the specification limits of 0.077" - 0.078" per product drawing.The sheath was functionally tested per the instructions for use (ifu) provided with this kit, which instructs the user, "ensure dilator is in position and locked to hub of sheath." the returned dilator was removed and reinserted through the sheath and passed with little to no resistance.The dilator hub was also able to successfully lock into the sheath hub.The manufacturing unit stated that 100% inspections are performed during assembly that would detect this defect.R & d unit proposed multiple potential causes for the damage.They stated that during manufacturing, the sheath tip could get stuck on the tipping pin and became inverted when removed, but this would likely be identified by the tipping or assembly operator.There are also both functional and visual inspections performed as part of the sheath/dilator assembly process that should have identified the inverted tip if it happened at, or prior to, assembly.Alternatively, r & d stated that it's possible that the dilator was not locked in place at the time of insertion based on the customer comment that the dilator "kept sliding backwards out of the sheath".This could result in the sheath tip to be pulled/pushed as observed.During insertion, the dilator hub is intended to lock into the sheath hub as outlined per ifu statement "ensure dilator is in position and locked to hub of sheath." the ifu provided with the 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 venospasm, vessel perforation, bleeding, or component damage".A device history record review was performed, and no relevant findings were identified.Based on the appearance of the damage, the customer report that the defect was observed during use, and the comments from manufacturing and r & d, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW AGBA PICC NAVICURVE: 2L 5.5FR X 55CM BP
• Common Device Name: CATHETER, INTRAVASCULAR, THERA
• 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: 18707364
• Report Number: 9680794-2024-00103
• Device Sequence Number: 8518197
• Product Code: LJS
• UDI-Device Identifier: 10801902208702
• UDI-Public: 10801902208702
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K220363
• 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): 01/25/2024

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 Expiration Date: 12/31/2024
• Device Catalogue Number: DLX-45552-CURVB
• Device Lot Number: 33F23K0517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2024
• Supplement Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 02/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2023
• 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