MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 4 FR X 8 CM; CATHETER, PERCUTANEOUS

Catalog Number CS-15402-E

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pleural Effusion (2010); Pericardial Effusion (3271)

Event Date 04/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The patient's condition is reported as fine.However, the patient is still in the hospital because of prematurity.Additional information: the x ray performed after the surgery did not show a migration of the catheter.The cardiorespiratory insufficiency and right pleural effusion and pericardial effusion has no link with the condition of the baby who was in the resuscitation room for a ileo-colic resection that finished a stoma.Intervention: the incident lead to a treatment with norepinephrine (up to 0.48 g / kg /min) and dobutamine (at a maximum dose of 0.9 g / kg / min).The catheter was removed and placement of a new catheter in the left clavicle.

Event Description

It was reported that: in the resuscitation room, concerning a premature new-born baby who had a surgery on (b)(6) 2018 for ileo-colic resection with insertion of a stoma.A pediatric cvc is inserted in the supraclavicular way during the intervention.The newborn is then sent to intensive care.On (b)(6) 2018, discovery of a "perfusothorax" (migration of the catheter) with cardiorespiratory insufficiency.With also a right pleural effusion and circumferential pericardial effusion.Clinical consequences: hypotension and anuria requiring the increase of noradrenaline (up to 0.48 g / kg / min) and introduction of dobutamine (at the maximum dose of 0.9 g / kg / min).Life-threatening.Catheter was removed and replaced by a left supraclavicular catheter.

Event Description

It was reported that: in the resuscitation room, concerning a premature new-born baby who had a surgery on (b)(6) 2018 for ileo-colic resection with insertion of a stoma.A pediatric cvc is inserted in the supraclavicular way during the intervention.The newborn is then sent to intensive care.On the (b)(6) 2018, discovery of a "perfusothorax" (migration of the catheter) with cardiorespiratory insufficiency.With also a right pleural effusion and circumferential pericardial effusion.Clinical consequences: hypotension and anuria requiring the increase of noradrenaline (up to 0.48 g / kg / min) and introduction of dobutamine (at the maximum dose of 0.9 g / kg / min).Life-threatening.Catheter was removed and replaced by a left supraclavicular catheter.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 8 CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7515528
• MDR Text Key: 108301428
• Report Number: 3006425876-2018-00294
• 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: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: CS-15402-E
• Device Lot Number: 71F17H0453
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention