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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7FR X 20CM CATHETER PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7FR X 20CM CATHETER PERCUTANEOUS Back to Search Results
Catalog Number EU-15703-CVT
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Low Blood Pressure/ Hypotension (1914)
Event Date 08/07/2017
Event Type  Death  
Manufacturer Narrative

Concomitant medical products: dr#3006435876-2017-00336, (b)(4). The device is not intended for sale in the us. Similar device sold in the us. According to the correspondence received from the user facility, the cvc was sutured only at the clamp/fastener and not at the hub. This is contrary to the product instructions for use, which requires suturing at the junction hub as the primary suture site, with the clamp/fastener as the secondary suture site. A companion report for the same incident has been filed for the clamp component noted in concomitant medical products.

 
Event Description

The customer alleges that the catheter shoved out of the fastener. The customer reports that they only put a suture on the clamp and no suture on the hub of the primary catheter itself. The catheter clamp used by the user facility is for catalog# eu-00007-cc and is documented in mdr# 3006425876. During shifting of the patient, it was noted that the line had slipped out, causing an interruption in the administration of inotropic medication. A new catheter was placed (femoral placement). After dislocation of the initial cvc, the patient's blood pressure decreased such that the patient needed resuscitation. During resuscitation a bleed occurred. The thorax was re-opened. The patient clinically worsened and died.

 
Manufacturer Narrative

Continuation of medical devices:dr#3006435876-2017-00336. (b)(4). A device history record (dhr) review was performed and no relevant findings were identified. The reported complaint that catheter migrated could not be confirmed as a sample was not provided for evaluation. Although a sample was not provided for this complaint, the customer confirmed that the cvc was not fixed according to the instructions for use (ifu). The catheter was sutured and secured using only the box clamp, instead of using the triangular juncture hub as the primary suture site and the box clamp as a secondary suture site as necessary. Based on the information received, the primary cause of this complaint is operational context. Teleflex has sent the customer a letter that explains "how to secure the catheter".

 
Event Description

The customer alleges that the catheter shoved out of the fastener. The customer reports that they only put a suture on the clamp and no suture on the hub of the primary catheter itself. The catheter clamp used by the user facility is for catalog# eu-00007-cc and is documented in mdr# (b)(4). During shifting of the patient, it was noted that the line had slipped out, causing an interruption in the administration of inotropic medication. A new catheter was placed (femoral placement). After dislocation of the initial cvc, the patient's blood pressure decreased such that the patient needed resuscitation. During resuscitation a bleed occurred. The thorax was re-opened. The patient clinically worsened and died.

 
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Brand NameARROW CVC SET: 3-LUMEN 7FR X 20CM
Type of DeviceCATHETER PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
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
9194334854
MDR Report Key6833590
MDR Text Key84085243
Report Number3006425876-2017-00313
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeNL
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 08/10/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/31/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberEU-15703-CVT
Device LOT NumberUNKNOWN
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 Received10/04/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 08/31/2017 Patient Sequence Number: 1
Treatment
CLAMP CATHETER COMPONENT (CATALOG# EU-00007-CC)M
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