MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN/PSI SET; CATHETER, INTRAVASCULAR, THER

Catalog Number SI-21142

Device Problems Difficult to Remove (1528); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The preliminary visual evaluation of the returned device indicates swg (spring wire guide) separated.

Event Description

The customer reports: during the process of passing the cvc, it was noticed that when removing the swg it was kinked and is very difficult to remove.

Event Description

The customer reports: during the process of passing the cvc, it was noticed that when removing the swg it was kinked and is very difficult to remove.

Manufacturer Narrative

Qn#(b)(4).The customer returned one guide wire for evaluation.The guide wire was returned in two separate pieces.The device contained obvious signs of use in the form of biological material.Visual examination revealed kinks throughout the guide wire body.Only one weld was present, indicating that the other weld was separated and not returned.Microscopic examination confirmed that the core wire was broken about halfway down the guide wire body.The fractured points contained signs of necking, indicating that undue force contributed to the breakage.The outer diameter of the returned guide wire was measured and was within specification.The two pieces of core wire measured to be 254 mm and 198 mm which is a total of 452 mm.This indicates that the entire core wire was returned as the specifications are 450-458 mm per product drawing.A manual tug test confirmed that the presumed distal weld was fully intact.A device history record review was performed with no relevant findings.The instructions-for-use (ifu) provided with this product describes suggested techniques to minimize the likelihood of guide wire damage during use.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 customer report of a separated guide wire was confirmed by complaint investigation of the returned sample.The guide wire was fractured about halfway down the wire.The damage was consistent with undue force being applied to the guide wire body.No manufacturing defects were found during this investigation.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the bs en iso 11070:2014 standard of 2.2 pounds force for this size wire.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Quarterly trending indicates a low, stable rate for unraveled guide wire complaints.Based on these circumstances, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW MULTI-LUMEN/PSI SET
• Type of Device: CATHETER, INTRAVASCULAR, THER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8697033
• MDR Text Key: 147932730
• Report Number: 9680794-2019-00222
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K002507
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 05/29/2019

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: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: SI-21142
• Device Lot Number: 14F17K0596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2019
• Initial Date Manufacturer Received: 05/29/2019
• Initial Date FDA Received: 06/13/2019
• Supplement Dates Manufacturer Received: 07/15/2019
• Supplement Dates FDA Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1