MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 22 GA X 4" (10 CM); CATHETER, PERCUTANEOUS

Catalog Number ES-04522

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 04/03/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).The teleflex sales rep.Met with the doctor at the (b)(4) hospital.The doctor indicates to the teleflex sales rep.The following: the catheter was inserted and an x-ray was performed.The catheter remained fully functional until the 4th day.On the 4th day, while the clinical picture was showing a decrease heart rate it was decided to inject adrenaline and there was no reaction.An ultrasound was performed which revealed an accumulation of liquid in the pericardium which resulted in cardiac arrest, by compression, then respiratory arrest.An intra-pericardial puncture was performed.The analysis revealed the presence of parenteral nutrition solution.The doctors concluded a cardiac tamponade and indicated that the teleflex device absolutely was not the cause of the incident.The institution will reinforce controls when cvcs are inserted.

Event Description

The customer reports that an infant (b)(6) with birth weight of (b)(6) and premature ((b)(6)) was born in a twin pregnancy context.The infant had polyform malfunctions (duodenal atresia and atrio-ventricular canal) and a suspicion of down syndrome.A cvc catheter was placed (under the subclavian muscle) during surgery for duodenal diaphragm.The control after insertion of the cvc showed that the distal end (tip) projected toward the lower part of the right cavities.Four days after insertion of the cvc, the patient presented with a perfusion-pericardium with 30 ml of pericardial effusion.This resulted in an obstructive respiratory stop, and then death of the patient by respiratory insufficiency linked to respiratory distress syndrome post circulatory stop.

Manufacturer Narrative

Qn#(b)(4).The customer indicated that the sample in question was not available to return for evaluation.A device history record review was performed on the catheter and no relevant findings were identified.The instructions-for-use (ifu) supplied with this product warns the user that indwelling catheters should be routinely inspected for desired flow rate, security of dressing, correct catheter position and for secure luer-lock connections.The ifu also provides instructions on correct suturing of the catheter to ensure migration/damage does not occur.

Event Description

The customer reports that an infant (b)(6) with birth weight of (b)(6) and premature ((b)(6)) was born in a twin pregnancy context.The infant had polyform malfunctions (duodenal atresia and atrio-ventricular canal) and a suspicion of down syndrome.A cvc catheter was placed (under the subclavian muscle) during surgery for duodenal diaphragm.The control after insertion of the cvc showed that the distal end (tip) projected toward the lower part of the right cavities.Four days after insertion of the cvc, the patient presented with a perfusion-pericardium with 30 ml of pericardial effusion.This resulted in an obstructive respiratory stop, and then death of the patient by respiratory insufficiency linked to respiratory distress syndrome post circulatory stop.

• Brand Name: ARROW CVC SET: 22 GA X 4" (10 CM)
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6633152
• MDR Text Key: 77296871
• Report Number: 1036844-2017-00231
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: ES-04522
• Device Lot Number: 23F15A0667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2015
• 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
• Patient Outcome(s): Death
• Patient Age: 1 MO
• Patient Weight: 2