MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS

Model Number IPN918831

Device Problems Migration or Expulsion of Device (1395); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 01/26/2022

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

The complaint is reported as: "the patient was moved from the operating table and to his bed after the surgery.There was a supposed traction but very usual and with nothing special, on the central catheter positioned in right internal jugular.The junction hub got teared off at the level of the fixation wings.Suture thread remained in place on the skin as well as bandage." it was reported the consequence was "sudden discontinuation of drugs (amines) infused via the catheter" and "the puncture hole was compressed to avoid any hemorrhagic or embolic risk".A new catheter was inserted on the left internal jugular.

Event Description

The complaint is reported as: "the patient was moved from the operating table and to his bed after the surgery.There was a supposed traction but very usual and with nothing special, on the central catheter positioned in right internal jugular.The junction hub got teared off at the level of the fixation wings.Suture thread remained in place on the skin as well as bandage." it was reported the consequence was "sudden discontinuation of drugs (amines) infused via the catheter" and "the puncture hole was compressed to avoid any hemorrhagic or embolic risk".A new catheter was inserted on the left internal jugular.

Manufacturer Narrative

(b)(4).The customer returned one 4-l cvc for analysis.Signs of use in the form of biological material was observed inside the extension lines.Visual inspection of the catheter revealed both suture wings on the juncture hub are torn.The separation points appeared rough and jagged, which is consistent with undue force being applied to the wings when suturing the catheter.The separated suture wings would lead to separation of the catheter from the suture location , and therefore catheter migration.The catheter body total length measured 158 mm which is within the specification of 157mm - 177mm per catheter product drawing.A device history record review was performed and no relevant findings were identified.The instructions for use (ifu) provided with this kit informs the user, "use triangular juncture hub with side wings as primary suture site.Use catheter clamp and fastener as a secondary suture site as necessary".The ifu also states, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested" the report of a catheter migration could not be fully confirmed by complaint investigation of the returned sample.Without a customer-supplied photo, there is insufficient evidence to confirm the migration of the catheter.However, visual inspection revealed both suture wings at the juncture hub were torn.This damage is consistent with undue force being applied to the suture wings, and the catheter migration is likely to have occurred as a result of the torn suture wings and loss of stabilization of the catheter at the suture site.The customer report indicated that the event occurred as "the patient was moved from the operating table and to his bed after the surgery" which likely contributed to the event.The catheter passed all relevant dimensional inspection, and a device history record review was performed with no relevant findings.Based on the sample returned and the customer report, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 16CM
• 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: 13595147
• MDR Text Key: 286253724
• Report Number: 3006425876-2022-00177
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/07/2022

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 Model Number: IPN918831
• Device Catalogue Number: EU-12854-N
• Device Lot Number: 71F21D1174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/07/2022
• Initial Date FDA Received: 02/24/2022
• Supplement Dates Manufacturer Received: 03/25/2022
• Supplement Dates FDA Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2021
• 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: AMINES IV INFUSION; AMINES IV INFUSION