MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB; CATHETER INTRAVASCULAR THERAP

Catalog Number CDA-45703-P1A

Device Problems Material Frayed (1262); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: during the installation, there was difficulty in removing thee guide, and it was removed together with the catheter, it came out frayed.Another device was used without incident.

Event Description

The customer reports: during the installation, there was difficulty in removing thee guide, and it was removed together with the catheter, it came out frayed.Another device was used without incident.

Manufacturer Narrative

(b)(4).The customer returned a single guide wire for evaluation.The catheter was not returned.The guide wire was unraveled and showed evidence of use.Visual examination revealed the guide wire is unraveled from the proximal weld and has multiple kinks in the guide wire body.The proximal core wire is exposed out of the coil wire.The distal j-bend is slightly deformed but is intact.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the proximal weld and that the weld was present at the end of the coil wire.The exposed broken proximal core wire tip is pinched at the point of separation.Both welds appeared full and spherical.Visual inspection of the catheter could not be performed as the catheter was not returned.The major kinks in the guide wire body were measured at 254, 354 and 497 mm from the proximal tip.The broken core wire measured 602 mm in length, which is within the specification of 596-604 mm per drawing; therefore no pieces of the core wire appear to be missing.The outside diameter of the guide wire was also within specification.The undamaged distal end of the guide wire was able to advance through a lab inventory 18ga introducer needle and arrow raulerson syringe with minimal resistance.The proximal end could not be tested due to the damage.A manual tug test confirmed that the distal 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 returned guide wire was unraveled and the core wire was broken adjacent to the proximal weld.Dimensional inspection and a device history record review did not reveal any evidence of a manufacturing related issue.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, 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.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
• Type of Device: CATHETER INTRAVASCULAR THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8408022
• MDR Text Key: 138387644
• Report Number: 9680794-2019-00071
• 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: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: CDA-45703-P1A
• Device Lot Number: 13R17E9095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2019
• Date Manufacturer Received: 04/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR