MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARTERIAL CATH SET: 20 GA X 8CM; CATHETER PERCUTANEOUS

Catalog Number SAC-00820-PBX

Device Problem Material Twisted/Bent (2981)

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

Event Date 02/23/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: "the guide was found to be bent in the package during incoming inspection/inventory review, product training/d demonstration.There was no patient involvement.".

Manufacturer Narrative

Qn# (b)(4).The customer returned one, unopened sac kit for evaluation.The kit was opened to further inspect the returned components.Visual inspection of the returned guide wire revealed several kinks throughout the body.Creasing was observed on the guide wire protective tubing and the kit packaging, in the same approximate locations as the guide wire kinks.Microscopic examination confirmed the damage.Both welds were present and appeared full and spherical.The damage observed is consistent with defects related to storage and shipping.The lidstock clearly states "do not bend".The kinks in the guide wire were located 99mm, 162mm, and 307mm from the proximal end.The guide wire total length measured 351mm which is within the specifications of 345mm-355mm per product drawing.The guide wire outer diameter measured 0.51mm which is within the specifications of 0.508mm-0.533mm per product drawing.Functional inspection of the guide wire was performed per the instructions-for-use (ifu) provided with the kit which states, "insert desired tip of spring-wire guide through introducer needle into artery (until depth-marking [if provided] on wire enters hub of needle).Thread tip of indwelling catheter over spring-wire guide." the undamaged portions of the guide wire were threaded through the returned 20 ga introducer needle with no resistance.A manual tug test confirmed the distal and proximal welds were attached.The manufacturing site was previously consulted regarding the observed failure mode for related complaints.They indicated that the observed kink, in addition to the creasing in the packaging, is consistent with damage caused by shipping and handling.As part of the guide wire manufacturing process, each guidewire is passed through a ring gauge so it is unlikely that this defect would have been present prior to release from the manufacturing site.A device history record review was performed with no relevant findings.The instructions for use (ifu) provided with this kit warns the user , "precaution: use of excessive force may damage catheter or guidewire.Do not use if package is damaged." the customer report of a kinked guide wire prior to use was confirmed through complaint investigation of the returned sample.Several kinks were observed on the guide wire body.In addition, several folds and creases were observed on the outside packaging.The guide wire met all relevant dimensional requirements, and a device history record review was performed with no relevant findings.The lidstock clearly states "do not bend." based on the customer description and the sample received, storage and shipping caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported that: "the guide was found to be bent in the package during incoming inspection/inventory review, product training/d emonstration.There was no patient involvement.".

• Brand Name: ARTERIAL CATH SET: 20 GA X 8CM
• Type of Device: CATHETER PERCUTANEOUS
• 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: 19058825
• MDR Text Key: 339578768
• Report Number: 3006425876-2024-00340
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K093050
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

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 Operator: Health Professional
• Device Catalogue Number: SAC-00820-PBX
• Device Lot Number: 71F22K2525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2022
• 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: N/A.; N/A.