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

Catalog Number CV-25703

Device Problems Kinked (1339); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: when the catheter is passed, there is evidence of damage to the metal guide, it does not pass and another catheter must be requested.A delay was reported without issue.

Manufacturer Narrative

(b)(4).The customer returned a single guide wire and the product lidstock for evaluation.The catheter was not returned.Visual examination revealed the guide wire is kinked in many locations along the body.The distal j-bend was slightly deformed but intact.Microscopic examination confirmed the kinks in the guide wire body.Both welds were present and were observed to be full and spherical.The major kinks in the guide wire were located 57, 130, 190, 248, 302, 364, 375 and 532 mm from the distal tip.The guide wire outer diameter and overall length were measured and were found to be within specification.The guide wire was advanced through a lab inventory ars and a lab inventory 18ga introducer needle to functionally test the guide wire.The guide wire passed through both components with minimal resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed on the guide wire and catheter and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with this product describes suggested techniques to minimize the likelihood of guide wire damage during use.(con't) other remarks: the ifu cautions that if resistance is encountered when attempting to remove the spring-wire guide after catheter placement, the spring-wire may be kinked about the tip of the catheter within the vessel which may result in undue force being applied resulting in spring-wire guide breakage.If resistance is encountered, withdraw the catheter relative to the spring-wire guide about 2-3 cm and attempt to remove the spring-wire guide.If resistance is again encountered, remove the spring-wire guide and catheter simultaneously.The report that the guide wire kinked during use was confirmed through examination of the returned sample.The guide wire was kinked in several locations along the body; however, the catheter was not returned for evaluation.The returned guide wire met all relevant dimensional requirements and a device history record review did not identify any manufacturing related issues with the catheter.Based on these circumstances, it was determined that operational context likely contributed to this event, however, the probable cause of guide wire and catheter resistance could not be determined based upon the information provided and without the catheter being returned.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports: when the catheter is passed, there is evidence of damage to the metal guide, it does not pass and another catheter must be requested.A delay was reported without issue.

• Brand Name: ARROW CVC SET: 3-LUMEN 7FR X 20CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7537654
• MDR Text Key: 109045999
• Report Number: 3006425876-2018-00321
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/09/2019
• Device Catalogue Number: CV-25703
• Device Lot Number: 71F17D2530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Date Manufacturer Received: 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR