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 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).Potential lot#: 14f19m0148.

Event Description

The md was preparing the procedure and checked the product.The md found that the swg (spring wire guide) was bent.A new device was obtained.

Event Description

The md was preparing the procedure and checked the product.The md found that the swg (spring wire guide) was bent.A new device was obtained.

Manufacturer Narrative

Qn#(b)(4).The customer returned one swg in the advancer tubing, a catheter, ars, two dilators and a transduction probe for evaluation.There was no evidence of use on any of the returned components.Visual examination of the returned swg confirmed the guide wire is kinked along its body.The kinked section would not have been protected during shipping, indicating that the guide wire likely was damaged during shipment.The distal j-bend was intact.Both welds appeared spherical and fully formed.The returned guide wire was kinked 427 mm from the proximal tip.The total length of the guide wire measured to be 452 mm which is within specifications of 444-456 mm per product drawing.The outer diameter of the returned guide wire measured to be 0.443 mm which is within specifications of 0.43-0.47 mm per product drawing.The undamaged portions of the returned wire guide passed through the returned dilators and distal lumen of the catheter and lab inv.21 ga introducer needle with minimal resistance.A manual tug test confirmed the distal and proximal welds were fully attached.A device history record review was performed with no relevant findings identified.The instructions for use (ifu) provided with the kit informs the user, "read all package insert warnings, precautions, and instructions prior to use.Failure to do so may result in severe patient injury or death." "do not use if package is damaged" the customer report of guide wire damage before use was confirmed by complaint investigation of the returned sample.The sample passed all relevant dimensional and functional testing, and a device history record review was performed with no relevant findings.The guide wire was returned within its advancer tubing.The tubing showed no kinks or stress marks.The portion of the guide wire that kinked was not protected by the advancer tubing.Based on the condition of the guide wire and the report that the damage was observed before use, storage and shipping caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Manufacturer Narrative

Qn#(b)(4).Corrected data: results code corrected to (b)(4).

Event Description

The md was preparing the procedure and checked the product.The md found that the swg (spring wire guide) was bent.A new device was obtained.

• 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: 10349964
• MDR Text Key: 201743199
• Report Number: 9680794-2020-00319
• 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,Followup
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• 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: 08/03/2020
• Date Manufacturer Received: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1