MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 5 FR X 13 CM; CATHETER PERCUTANEOUS

Model Number IPN036090

Device Problems Unraveled Material (1664); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/22/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported that: event involved a (b)(6) old male patient, (b)(6).The distal end of the guide was kinked.During the removal of the guide, while pulling on the distal side of the guide, the guide unraveled and broke.The guide was fully removed.Clinical consequences: there was no consequence for the patient because the distal remained outside the patient all the time.An x ray of the thorax was performed and there was no appearance of the guide.

Event Description

It was reported that: event involved a 14 years old male patient, 50 kg.The distal end of the guide was kinked.During the removal of the guide, while pulling on the distal side of the guide, the guide unraveled and broke.The guide was fully removed.Clinical consequences: there was no consequence for the patient because the distal remained outside the patient all the time.An x ray of the thorax was performed and there was no appearance of the guide.

Manufacturer Narrative

(b)(4).The customer returned one spring wire guide (swg) for evaluation.The guide wire was observed to be separated at the proximal end with the proximal weld missing.Microscopic examination confirmed the distal weld was present and observed to be full and spherical.The overall length of the core wire measured 415 mm, which is within the specification of 449.2-458.8 mm per guide wire product drawing.This implies that at least 34.2 mm of core wire was not returned.The outer diameter of the undamaged portion of the guide wire measured 0.523 mm which is within the specification of 0.508-0.533 mm per guide wire product drawing.The undamaged portions of the swg were advanced through a lab inventory 20ga introducer needle to functionally test the guide wire.The guide wire passed through with minimal resistance.A manual tug test confirmed that the distal weld was 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 the kit 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.Do not cut spring-wire guide to alter length.Do not withdraw spring-wire guide against needle bevel to minimize the risk of possible severing or damaging of spring-wire guide." the report that the guide wire was separated during use was confirmed through examination of the returned sample.The guide wire was observed to be separated at the proximal end with the proximal weld missing.The guide wire met relevant dimensional and functional requirements and a device history record review did not identify any manufacturing related issues.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.0 pounds force.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.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.

• Brand Name: ARROW CVC SET: 2-LUMEN 5 FR X 13 CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10493744
• MDR Text Key: 206341712
• Report Number: 3006425876-2020-00777
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

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 Expiration Date: 04/09/2024
• Device Model Number: IPN036090
• Device Catalogue Number: CS-14502
• Device Lot Number: 71F19D0739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 09/04/2020
• Supplement Dates Manufacturer Received: 10/06/2020
• Supplement Dates FDA Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Weight: 50