MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 16 GA X 27-1/2"; CATHETER, INTRAVASCULAR, THERA

Catalog Number AJ-01671

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Preliminary evaluation of the retuned device indicates swg/ars resistance kinked.

Event Description

The customer reports the user felt resistance/uncomfortable at the tip of the swg (spring wire guide) during insertion of the swg in the ars (syringe).A new kit was obtained for use.

Event Description

The customer reports the user felt resistance/uncomfortable at the tip of the swg (spring wire guide) during insertion of the swg in the ars (syringe).A new kit was obtained for use.

Manufacturer Narrative

Qn#(b)(4).The customer returned the product lidstock, an arrow raulerson syringe (ars), a spring-wire guide (swg) assembly and an introducer needle for evaluation.The guide wire was returned with the proximal end inside the swg tubing and the distal tip advanced through an ars and an introducer needle cannula.Visual examination of the swg revealed multiple offset coils on the j-bend tip and a slight bend in the swg body.The ars and introducer needle contained no defects or anomalies.The bend in the swg body was located approximately 195 mm from the distal weld.The offset coils on the j-bend tip were located approximately 7-13 mm from the distal weld.The length and outer diameter of the swg were measured and were found to be within specification.The guide wire was able to be advanced through the returned syringe and introducer needle with minimal resistance, despite the offset coils and bend found during visual ins pection.A manual tug test confirmed that both the proximal and distal welds were intact.A device history record review was performed on the introducer needle, guide wire, and ars and no relevant manufacturing issues were identified.(con't) other remarks: the ifu provided with this kit warns the user, "do not withdraw spring-wire guide against needle bevel to minimize the risk of possible severing or damaging of spring-wire guide." the report that the guide wire kinked during use was confirmed through examination of the returned sample.The guide wire distal j-bend tip contained offset coils, and the swg body contained a bend.The returned guide wire, introducer needle and ars all met all relevant functional/dimensional requirements and a device history record review did not identify any manufacturing related issues.In addition, the returned guide wire was able to pass through the ars and introducer needle with minimal resistance.Based on the condition of the returned guide wire and the report that the damage was observed during use, it was determined that operational context caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 16 GA X 27-1/2"
• Type of Device: CATHETER, INTRAVASCULAR, THERA
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7614810
• MDR Text Key: 111678003
• Report Number: 3003737899-2018-00078
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K042126
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: AJ-01671
• Device Lot Number: 14F17F0295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Date Manufacturer Received: 07/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1