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

Catalog Number EU-15703-CVT

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information - the customer indicates that the cvc migrated.Patient condition is reported as good.The device is not intended for sale in the us.Similar device sold in the us.

Event Description

The customer reports: "the cvc got out of its fixation and the cvc was attempting to fall out.This probably happened as the bandage was changed on the (b)(6) 2018.The cvc was fixated with a new bandage.".

Manufacturer Narrative

(b)(4).The customer provided two photos for this complaint.Both photos display the suture site on the patient's body.The catheter appears to be primarily sutured at the box clamp and part of the catheter is out of the box clamp.One 3-lumen cvc catheter was returned for evaluation.The sample had evidence of use and the catheter body was partially inside the box clamp.Visual examination with the naked eye did not reveal any defects or anomalies.The catheter box clamp appeared used but undamaged and there was string inside one of the juncture hub wings.Microscopic examination of the juncture hub suture wings of the catheter (primary suture site) did not reveal any damage or defects.Evidence of use was observed on the catheter box clamp; however, no damage was observed.The catheter body outer diameter, the catheter clamp fastener inner diameter, and the catheter clamp inner diameter were measured and were found to be within specification.The clamp and the clamp fastener were reassembled.The largest pin gauge that would pass through the clamp assembly without resistance was 0.084".This indicates that the clamp would securely hold a catheter that has an outer diameter of 0.0967" (2.457 mm).The box clamp was placed on the catheter and the catheter body was then tugged on either side.The catheter remained in place.No lot number was provided was provided by the customer; therefore, a device history record review was performed based on the sales history of the customer.A device history record review was performed on the catheter and box clamp components and no relevant findings were identified.The instructions-for-use (ifu) provided with this kit states to use the triangular juncture hub with side wings as primary suture site.The catheter clamp and fastener should be used as a secondary suture site if necessary.The customer did not state whether or not the primary suture site was used.The provided photos displays the box clamp assembly being used as the primary suture site.The ifu also states to secure catheter clamp and fastener as a unit to patient by using either catheter stabilization device, stapling or suturing.Both catheter clamp and fastener need to be secured to reduce risk of catheter migration.It was reported that the cvc catheter migrated out of the patient while in use.The reported issue could not be confirmed through functional or dimensional testing of the returned sample.The catheter remained secure in the catheter clamp when it was tugged and the components met all relevant dimensional specifications.A device history record review did not reveal any manufacturing related issues.The ifu states to use the triangular juncture hub with side wings as primary suture site.The catheter clamp and fastener should be used as a secondary suture site if necessary.The customer did not report whether the primary suture site (juncture hub) was used; however, the provided photos displayed the box clamp assembly being used as the primary suture site.Based on the information provided and investigation of the provided sample, the probable cause of this complaint is user error.Based on the information and sample provided the customer did not follow the ifu.An in-service request has been initiated to further investigate this complaint issue.

Event Description

The customer reports: "the cvc got out of its fixation and the cvc was attempting to fall out.This probably happened as the bandage was changed on the (b)(6) 2018.The cvc was fixated with a new bandage.".

• Brand Name: ARROW CVC SET: 3-LUMEN 7FR X 20CM
• Type of Device: CATHETER, 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 Key: 7251301
• MDR Text Key: 99356837
• Report Number: 3006425876-2018-00112
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: EU-15703-CVT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2018
• Initial Date FDA Received: 02/08/2018
• Supplement Dates Manufacturer Received: 03/06/2018
• Supplement Dates FDA Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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