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

Catalog Number CA-25703-A

Device Problems Difficult to Remove (1528); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: catheter inserted easily, difficult to pull guidewire out of catheter after procedure.Complete catheter was pulled out and replaced.

Manufacturer Narrative

(b)(4).The customer returned an unraveled guide wire, a 3-lumen catheter and the product lidstock for evaluation.The components showed evidence of use in the form of dried blood.Visual examination revealed the guide wire is unraveled from the distal weld and is kinked/distorted in several locations along the body.The core wire distal j-bend was deformed and exposed out of the coil wire.The returned catheter showed evidence of use but no obvious defects or anomalies.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the distal weld.The exposed distal core wire tip is tapered and discolored at the point of separation.Both welds were present and appeared full and spherical.Microscopic examination of the catheter did not reveal any defects or anomalies.The major kinks in the guide wire body were measured at 25, 382, 489, 585 and 590 mm from the proximal tip.The broken core wire measured 602 mm in length, which is within the specification of 596-604 mm per product drawing; therefore no pieces of the core wire appear to be missing.The outside diameter of the guide wire, and the catheter body outer diameter and length were measured and all were found to be within specification.The catheter was flushed with water prior to functional testing and dried blood was observed exiting the catheter body.A lab inventory guide wire of same diameter as that supplied in kit (b)(4) passed through the distal extension line and catheter body of the returned catheter with minimal resistance.A manual tug test confirmed that the proximal weld was 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.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 unraveled was confirmed through examination of the returned sample.The core wire was broken adjacent to the distal weld.The guide wire and catheter met all functional/dimensional requirements during investigation testing.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.Based on these circumstances, it was determined that operational context caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The customer reports: catheter inserted easily, difficult to pull guidewire out of catheter after procedure.Complete catheter was pulled out and replaced.

• Brand Name: ARROW CVC KIT: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER, INTRAVASCULAR, THERA
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7868169
• MDR Text Key: 119940676
• Report Number: 3003737899-2018-00115
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K071538
• 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: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: CA-25703-A
• Device Lot Number: 13F18D0457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Date Manufacturer Received: 10/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1