MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS

Catalog Number CV-12853

Device Problem Kinked (1339)

Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)

Event Date 01/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information: based on the sample received the preliminary evaluation indicates the swg (spring wire guide)/ catheter resistance - kinked.

Event Description

The customer alleges the catheter cannot advance on the stylet.Another kit was used successfully.

Manufacturer Narrative

(b)(4).The customer returned one 3-lumen catheter and a guide wire for evaluation.Visual examination of the guide wire revealed one slight bend.Visual examination of the catheter did not reveal any damage or defects.The guide wire contained one bend 198mm from the proximal end.The length and outer diameter of the guide wire were measured and were found to be within specification.The length of the catheter body was also within specification.The returned catheter was advanced over the proximal tip of the returned guide wire in order to functionally test the components.The guide wire was able to advance through the catheter body but could not advance through the catheter juncture hub.When the guide wire was advanced from the distal extension lines it was able to fully pass through the catheter and out of the catheter distal tip.All three extension lines on the catheter were flushed with water and functioned as expected.No sign of blockage or interlumen crossover was observed.A device history record review was performed with no relevant findings.(con't) other remarks: the instructions for use (ifu) provided with this kit instructs the user, "if resistance is encountered, withdraw catheter relative to spring-wire guide about 2-3cm and attempt to remove spring-wire guide.If resistance is again encountered remove spring-wire guide and catheter simultaneously." the customer report of difficulty advancing the guide wire through the catheter was confirmed through functional testing of the returned components.The returned guide wire was unable to pass through the catheter juncture hub when advanced from the catheter distal tip.All returned components met all dimensional requirements.Based on the functional testing, the probable root cause is likely related to the manufacturing/molding of the catheter juncture hub.A non-conformance request has been initiated to further investigate this complaint issue.

Event Description

The customer alleges the catheter cannot advance on the stylet.Another kit was used successfully.

• Brand Name: ARROW CVC SET: 3-LUMEN 8.5FR X 16CM
• 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: 7247339
• MDR Text Key: 99214074
• Report Number: 3006425876-2018-00107
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K862056
• 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: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: CV-12853
• Device Lot Number: 71F17L1594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2017
• 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
• Patient Age: 50 YR
• Patient Weight: 105