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

Catalog Number CV-12853

Device Problems Kinked (1339); Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The preliminary evaluation of the returned device indicates the spring wire guide/catheter resistance - kinked.

Event Description

The customer reports the catheter did not go through inside the guide.It was stuck on the blue triangle just below the luer.A new kit was used.

Manufacturer Narrative

(b)(4).The customer returned one guide wire and catheter for evaluation.Visual examination of the guide wire revealed one kink near the proximal end and the j tip was slightly deformed.The coils were slightly closer together; however, they were not offset or unraveled.Visual examination of the catheter did not reveal any defects or anomalies.The guide wire contained one kink 31 mm from the proximal end.The total length and outer diameter of the guide wire were measured and were found to be within specification.The length of the returned catheter body was also within specification.The proximal end of the returned swg was advanced through the distal end of the returned catheter 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 line it was able to fully pass through the catheter and out of the catheter distal tip.All 3 extension lines were flushed with water and functioned as expected.A device history record review was performed and no relevant findings were identified.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 contained one kink, and was unable to pass through the catheter juncture hub when advanced from the catheter distal tip.Based on the functional testing, the probable root cause is likely related to the manufacturing/molding of the catheter juncture hub.A capa has been initiated by the manufacturing site to further investigate this complaint issue.

Event Description

The customer reports the catheter did not go through inside the guide.It was stuck on the blue triangle just below the luer.A new kit was used.

• 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: 7443997
• MDR Text Key: 106014989
• Report Number: 3006425876-2018-00267
• 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: 04/19/2018

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 Expiration Date: 02/28/2022
• Device Catalogue Number: CV-12853
• Device Lot Number: 71F17F2590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 04/19/2018
• Supplement Dates Manufacturer Received: 05/25/2018
• Supplement Dates FDA Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2017
• 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