MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI MIDLINE 1-L: 4FR X 20CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number EU-32041

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2024

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported "dilator catheter/ peel away sheath snapped while trying to remove it after line insertion".Additional information reports "only the peel away sheath broke".No patient harm or injury.No delay to therapy.The patient's current condition is reported as "fine".

Event Description

It was reported "dilator catheter/ peel away sheath snapped while trying to remove it after line insertion".Additional information reports "only the peel away sheath broke".No patient harm or injury.No delay to therapy.The patient's current condition is reported as "fine".

Manufacturer Narrative

(b)(4).The customer returned one peel-away sheath for evaluation.The sheath was completely split down the extrusion.Aside from the splitting, no obvious signs-of-use were observed.Visual inspection of the peel-away sheath revealed a separation adjacent to one of the tabs.Remains of the extrusion were still attached to the separated tab.The other tab was intact.The peel-away sheath length from the tab to the distal end measured 2 3/4", which is within the specifications of 2 5/8" - 2 7/8" per product drawing.The outer and inner diameters could not be accurately measured due to the condition of the returned sample.A device history record review was performed, and no relevant findings were identified.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 vessel perforation and bleeding, or component damage".The report of a separated peel-away sheath tab was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the sheath extrusion had separated from one of the tabs.Based on the customer report and the sample received, manufacturing likely caused or contributed to this event.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PI MIDLINE 1-L: 4FR X 20CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19165875
• MDR Text Key: 340879010
• Report Number: 3006425876-2024-00411
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

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: EU-32041
• Device Lot Number: 71F23F0073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2024
• Initial Date FDA Received: 04/23/2024
• Supplement Dates Manufacturer Received: 05/14/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED