MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CLAMP CATHETER COMPONENT; IV SECUREMENT DEVICE

Catalog Number EU-00007-CC

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Low Blood Pressure/ Hypotension (1914)

Event Date 08/09/2017

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: 017-00313, (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 (mdr# 3006425876-2017-00313) for the same incident has been filed for the cvc set 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 used by the user facility is for catalog# eu-15703-cvt cvc set and is documented in mdr# 3006425876-2017-00313.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

(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 used by the user facility is for catalog# eu-15703-cvt cvc set and is documented in mdr# 3006425876-2017-00313.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.

• Brand Name: ARROW CLAMP CATHETER COMPONENT
• Type of Device: IV SECUREMENT DEVICE
• 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 Key: 6837989
• MDR Text Key: 84349126
• Report Number: 3006425876-2017-00336
• Device Sequence Number: 1
• Product Code: PUK
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EU-00007-CC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2017
• Initial Date FDA Received: 09/01/2017
• Supplement Dates Manufacturer Received: 10/10/2017
• Supplement Dates FDA Received: 10/10/2017
• 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 Sequence Number: 1
• Treatment: CVC SET (CATALOG# EU-15703-CVT)(B)(4)
• Patient Outcome(s): Death