MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PSI KIT: 8.5 FR; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number CAN-09803

Device Problem Material Twisted/Bent (2981)

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

Event Date 03/14/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "protective sleeve covering the psi was sterilized in a bend position.Doctor was sure they cannot used it." this was found prior to use.Therefore no patient harm or injury.

Manufacturer Narrative

Qn#(b)(4).The customer provided one photo for analysis.The photo shows a psi sheath with a bend on the sheath ribs.The sheath extrusion is partially within the guard and the dilator is not pictured.The customer returned one psi sheath with its guard for analysis.The dilator was not returned which implies that the product was handled by the customer.No signs of use were observed on the returned sample.Visual analysis of the sheath revealed that the sheath body was bent at the location of the ribs.The ribs appeared extended when compared to a lab inventory psi sheath.The customer stated that the bend the in sheath was detected before the removal of the dilator from the assembly.A dilator from a lab inventory sheath ext assy w/ dilator (lf-09803-006) was inserted through proximally the distal tip of the sheath.Once the dilator was fully inserted within the sheath, the sheath and ribs appeared straightened as intended during the assembly process.Microscopic examination did not reveal other defects or anomalies with the ribs nor any other portion of the sheath body.No obvious defects or anomalies were observed on the guard.The location of the bend measured approximately 7 mm from the sheath hub.The length of the sheath from the hub to the distal tip measured 4.213", which is within the specification limits of 4" - 4 1/4" per the sheath ext assy w/ dilator product drawing.The sheath body outer diameter measured 0.144", which is within the specification limits of 0.138"-0.148" per the sheath ext assy w/ dilator product drawing.The psi sheath was functionally tested per the product instructions-for-use (ifu).The ifu provided with this kit instructs the user, "feed catheter through sheath/valve assembly into vessel.Advance catheter to desired position." a lab inventory 7.5 fr swann ganz catheter was inserted into the valve end of the sheath.Little to no resistance was encountered as the catheter was able to pass completely through the sheath body.The hemostasis valve and psi device were leak tested according to three different parameters per amrq-000037 rev.09: 1) low pressure leak resistance test (amrq-000037 section 6.1.2): this states, "there shall be no leakage past the hemostasis valve when using a pressure of 20-21 kpa (3psi)." the psi was attached to a leak tester.With the distal end of the sheath occluded, the sheath was pressurized to 21 kpa for 30 seconds.No leaks were observed, which indicates that the sheath valves are functioning as intended.2) liquid leakage - hemostasis valve with catheter advanced: the parameters from the low-pressure leak resistance test were repeated with a lab inventory 7.5 fr swan-ganz catheter inserted into the sheath.The sheath was pressurized to 42 kpa for 30 seconds and no leaks were observed at the valves.3) high pressure leak resistance test (amrq-000037 section 6.1.3): this states, "when tested in accordance with iso 11070: annex e, using a test pressure of 300-320kpa (43.5-46.4 psi), there shall be no leakage sufficient for form a falling drop." the psi was attached to a leak tester.With both the distal end of the sheath and the hemostasis valve occluded, the device was pressurized to 300 kpa for 30 seconds.No leaks were detected from any portion of the psi, which indicates that the sheath assembly is intact.R & d was previously contacted as a part of this complaint investigation.R & d stated that the ribs of the sheath are a fea ture that allows for more flexibility of the sheath without kinking; therefore, the bending seen in the returned sample is an intended feature of the sheath.The device is not compromised and the elongation at the ribs would still allow the sheath to flex without failure.A device history record review was performed, and no relevant findings were identified.The lidstock states, "psi kit for use with 7 - 7.5 fr.Catheters".The ifu provided with the kit informs the user, "warning: do not apply excessive force in removing guide wire, dilator or sheath.If withdrawal cannot be easily accomplished, a chest x-ray should be obtained and further consultation requested." the report of a bent sheath was able to be confirmed through complaint investigation of the returned sample.The returned sheath was bent at the site of its ribs.However, the sheath met all relevant dimensional and functional requirements including leak testing performed per iso 11070.R & d stated that the sheath is intended to bend and elongate at the ribs for flexibility.Based on the customer report, sample received, and comments from r & d, no problem was found with the returned sample.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported "protective sleeve covering the psi was sterilized in a bend position.Doctor was sure they cannot used it." this was found prior to use.Therefore no patient harm or injury.

• Brand Name: ARROW PSI KIT: 8.5 FR
• Type of Device: CATHETER,INTRAVASCULAR,THERAPE
• 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: 19103113
• MDR Text Key: 340563818
• Report Number: 9680794-2024-00332
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K071538
• 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: 03/21/2024

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: CAN-09803
• Device Lot Number: 33F23B0674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/14/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2023
• 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