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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. ARROW CVC SET: 22 GA X 4" (10 CM) CATHETER, PERCUTANEOUS Back to Search Results
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.

 
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Brand NameARROW CVC SET: 22 GA X 4" (10 CM)
Type of DeviceCATHETER, 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 Key6633152
MDR Text Key77296871
Report Number1036844-2017-00231
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
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 Received06/12/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device EXPIRATION Date09/30/2019
Device Catalogue NumberES-04522
Device LOT Number23F15A0667
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/13/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/12/2017 Patient Sequence Number: 1
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