MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 5-LUMEN 9.5FR X 20CM; CATHETER, PERCUTANEOUS

Catalog Number DE-15955-CB

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Anxiety (2328); No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint description for this event is entered for an issue with a 5-lumen catheter.A 5-lumen catheter is not sold in the us.Photos reviewed.The assumption is made, by this reviewer and vasc.Engrs., that the method by which the catheter was secured could potentially be the cause or issue with migration.A conservative decision is made that this will be a reportable event with focus on the securing devices of the product rather than an issue with the catheter.A device sample is reportable to be available for evaluation.

Event Description

It was reported that the catheter was dislocated despite the catheter fixation used according to the ifu.A catheter replacement was necessary and therefore an additional stress on the patient was unavoidable.

Manufacturer Narrative

(b)(4).Additional information received: an in-service was performed and the customer responded that they did suture the catheter directly to the patient at the juncture hub and box clamp and that the additional sutures on the returned sample was due to a strain relief.Follow up with the customer confirmed they sutured the catheter per the ifu as well as added additional strain relief.Based on the information provided and the investigation of the provided sample, it was determined that operational context caused or contributed to this event.

Event Description

It was reported that the catheter was dislocated despite the catheter fixation used according to the ifu.A catheter replacement was necessary and therefore an additional stress on the patient was unavoidable.

Manufacturer Narrative

(b)(4).The customer returned a single 5-lumen cvc catheter for evaluation.The catheter was returned with stopcocks on each of the luer hubs and dressing around the juncture hub.Evidence of use was observed on the catheter.Visual examination revealed that the box clamp was sutured directly to the juncture hub.The suture thread was attached to only one wing of the box clamp and to only one wing of the juncture hub.The box clamp and juncture hub are intended to be sutured directly to the patient skin.It was observed that the suture was pulling the box clamp fastener off of the clamp insert but no damage was observed to the box clamp.One of the extension lines was observed to be ballooned, however, this was not included in the customer complaint report.The catheter body outer diameter, the catheter clamp fastener inner diameter, and the catheter clamp inner diameter were measured and all 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 0.097".This indicates that the clamp would securely hold a catheter that has an outer diameter of 0.126".The box clamp was placed on the catheter and the catheter body was then tugged on either side.The catheter remained in place.A device history record review was performed on the catheter and clamp components and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with this kit describes instructions for securing the catheter to the patient.It states to "use triangular juncture hub with side wings as primary suture site" and to "use catheter clamp and fastener as a secondary suture site as necessary.Snap rigid fastener onto catheter clamp." the returned catheter was sutured from the juncture hub to the box clamp indicating that the catheter was not sutured correctly according to the ifu.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; however, the catheter was returned with the box clamp sutured directly to the juncture hub.The box clamp and the juncture hub are intended to be sutured directly to the patient rather than to each other.The ifu provided with this kit states "use triangular juncture hub with side wings as primary suture site" and to "use catheter clamp and fastener as a secondary suture site as necessary." based on the information provided and investigation of the provided sample, the probable cause of this complaint is user error as the customer did not follow the ifu.An in-service request has been initiated to address this complaint issue.

Event Description

It was reported that the catheter was dislocated despite the catheter fixation used according to the ifu.A catheter replacement was necessary and therefore an additional stress on the patient was unavoidable.

• Brand Name: ARROW CVC SET: 5-LUMEN 9.5FR 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: 7361416
• MDR Text Key: 103280617
• Report Number: 3006425876-2018-00191
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2018

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: DE-15955-CB
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2018
• Initial Date FDA Received: 03/22/2018
• Supplement Dates Manufacturer Received: 05/02/2018; 05/11/2018
• Supplement Dates FDA Received: 05/08/2018; 05/11/2018
• Was Device Evaluated by Manufacturer?: No
• 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