MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CG+ PICC/DELTA KIT: 1-L 4.5 FR X 40 CM; ARROWG+ARD CATHETER PRODUCTS

Catalog Number CDC-44041-VPS2

Device Problems Kinked (1339); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the catheter was being placed into the patient's arm.During insertion, the guide wire would not pass through the green echogenic needle.The clinician stated you could feel bumps where the wire changes consistency.As a result, an mst kit was opened to complete the procedure.There was no delay in treatment and no patient death or complications reported.

Manufacturer Narrative

(b)(4).The event was initially evaluated and determined to be non-reportable.The returned device was evaluated and the event was determined to be a result of a product malfunction, therefore it is reportable.Device evaluation: the report that the guide wire would not pass through the needle was not confirmed.Returned was one guide wire.No needle was returned.By design the returned nitinol guide wire is composed of a straight solid wire 39 cm long with an additional 6 cm of spring coil at the distal end.The spring coils were examined microscopically.Several displaced coils were observed 5.7 cm from the distal tip.The overall length of the guide wire measured 44.9 cm, which met specification of 43.75 - 46.25 cm per guide wire graphic.The od of the solid portion of the guide wire measured 0.460mm, which met specification of 0.41 - 0.47 mm per guide wire graphic.The od of the spring coils measured 0.442 mm other remarks: this dimension is not specified on the guide wire graphic.The device history records were reviewed and did not reveal any manufacturing related issues.The probable cause of the guide wire not passing through the needle could not be determined based upon the information provided and without a complete sample.No further action will be taken.

• Brand Name: CG+ PICC/DELTA KIT: 1-L 4.5 FR X 40 CM
• Type of Device: ARROWG+ARD CATHETER PRODUCTS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jamie hartz ; 2400 bernville road; reading, PA 19605
• MDR Report Key: 5917009
• MDR Text Key: 53557298
• Report Number: 1036844-2016-00486
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122545
• 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
• Report Date: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: CDC-44041-VPS2
• Device Lot Number: 23F16C0848
• Other Device ID Number: 00801902087898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2016
• 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