MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 4 FR X 13 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-24402

Device Problems Device Damaged Prior to Use (2284); Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).Lot# unknown.Potential lot#: 14f18e0068.

Event Description

The md found that the swg (spring wire guide)was bent.The md judged it as a defective product and used new product.

Manufacturer Narrative

Qn#(b)(4).The customer returned one swg in the advancer tubing for evaluation.There was no evidence of use on any of the returned components.Visual examination of the returned swg confirmed the kink in the guide wire body.During normal assembly, the kink in the coil of the guide would have been located inside the protective tube assembly, protecting it from damage.No damage was noted on the tub assembly.The distal j-bend was intact.Both welds appeared spherical and fully formed.The kink in the returned swg was located at 331 mm from the proximal end.The overall length of the guide wire measured 453 mm which is within specifications of 444-456 mm per guide wire product drawing.The outer diameter of the guide wire measured 0.444 mm, which is within the specification limits of 0.43-0.47 mm per the guide wire product drawing.The undamaged portions of the returned wire guide passed through a 21 ga introducer needle with minimal resistance.A manual tug test confirmed the distal and proximal welds were fully attached.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The instructions for use (ifu) provided with this product warns the user, "do not apply excessive force in removing guide wire or catheters.If withdrawal cannot be easily accomplished, a chest x-ray should be obtained and further consultation requested." the report that the spring wire guide was found to be kinked prior to use was confirmed through visual examination of the returned sample.The returned guide wire had one kink in its body.The swg passed all relevant dimensional and functional inspection.A device history record review was performed based on sales history with no relevant findings to suggest a manufacturing related cause.During normal packaging, the portion of the guide wire that kinked would have been located inside the protective tube assembly, protecting it from damage.Therefore, it cannot be confirmed when the guide wire was kinked.The root cause of this investigation is undetermined.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

The md found that the swg (spring wire guide)was bent.The md judged it as a defective product and used new product.

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 13 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10258709
• MDR Text Key: 198721800
• Report Number: 9680794-2020-00307
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CS-24402
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1