MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 2-LUMEN 8 FR X 16 CM; CATHETER, PERCUTANEOUS

Catalog Number AK-12802

Device Problems Bent (1059); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports kinking and bending issue with the guide wire.

Manufacturer Narrative

(b)(4).The customer returned a spring-wire guide (swg) for evaluation.Visual examination of the swg revealed a bend in the body.No other defects or anomalies were found.The j-bend tip was undamaged and the distal and proximal welds were intact, full, and spherical.The bend in the swg body was located approximately 220 mm from the proximal weld.The length and outer diameter of the swg were measured and were found to be within specification.A device history review was performed and did not reveal any manufacturing related issues.The instructions for use provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.It states that if resistance is encountered when attempting to remove the guide wire after catheter placement, the guide wire may be kinked about the tip of the catheter within the vessel.In this case it is recommended to withdraw the catheter relative to the guide wire about 2-3 cm and then attempt to remove the guide wire.The instructions caution that withdrawing the guide wire against the needle bevel or use of excessive force during removal could damage or break the wire.(con't) other remarks: the reported complaint of guide wire kinking was confirmed by complaint investigation.The guide wire contained one bend.A device history record review was performed with no relevant findings.Based on the sample received, it was determined that operational context caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

The customer reports kinking and bending issue with the guide wire.

• Brand Name: ARROW CVC KIT: 2-LUMEN 8 FR X 16 CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V; ave. washington 3701, edificio 4; colonia complejo industrial, las americas; chihuahua 31114 ; MX 31114
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7560537
• MDR Text Key: 109781978
• Report Number: 3003737899-2018-00061
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: AK-12802
• Device Lot Number: 13F18D0195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2018
• 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