MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-25703-E

Device Problems Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

When inserting swg (spring wire guide), it was bent and could not pass anymore.Md was unable to proceed with the product and used new product.

Manufacturer Narrative

Qn#(b)(4).The customer returned one spring wire guide (swg) within its advancer tubing and a 3-l cvc catheter for evaluation.Visual inspection of the swg revealed three kinks and one bend in the body.Microscopic examination of the swg confirmed that both welds were attached and fully spherical.The kinks in the swg body measured 492 mm, 505 mm, 515 mm from the proximal weld.The bend was located at 560 mm from the proximal weld.The total length of the swg measured 602 mm, which is within specifications of 596-604 mm per swg graphic.The outer diameter of the swg measured 0.803 mm which is within specifications of 0.788-0.826mm per swg graphic.The undamaged portions of the swg were inserted into a lab inventory ars, a lab inventory 18 ga introducer needle, and the returned catheter to functionally test.The swg passed through the ars and needle with minimal resistance.The swg encountered resistance when inserted into the catheter.The location of resistance was cut and confirmed it was blocked with biological material and not a manufacturing issue.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed on the guide wire and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with this kit warns the user, "do not apply excessive force in removing guide wire or catheter.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 in use was confirmed through the complaint investigation of the returned sample.The returned guide wire was found to have one bend and three kinks in the body.The returned guide wire met all relevant dimensional requirements and a device history record review was completed and did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed during use, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

When inserting swg (spring wire guide), it was bent and could not pass anymore.Md was unable to proceed with the product and used new product.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10178764
• MDR Text Key: 196060696
• Report Number: 3006425876-2020-00541
• 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: 06/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/20/2020
• Device Catalogue Number: CS-25703-E
• Device Lot Number: 71F19A1897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1