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

Catalog Number CV-15703

Device Problem Split (2537)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports the guide is in poor condition because it was deformed when passing it and when it was removed it was split.The device was replaced and a delay was reported without issue.

Manufacturer Narrative

(b)(4).The customer returned a cv-15703 kit with multiple components.The spring-wire guide (swg) was used for this investigation.The returned swg was separated into two pieces and unraveled.Visual inspection of the two pieces of the swg revealed the guidewire coil wire is unraveled from the middle.The core wire protruding from each separated piece was curved and rounded.This indicates that core wire came in contact with a needle bevel.The j-tip bend was slightly deformed, but retained its j-shape.The guide wire body also has multiple bends in the inner core wire and stretched and offset coils.Microscopic examination of the swg revealed both the proximal and distal welds were intact, full, and spherical, and confirmed that the swg is only fractured at the separation point.The length of the distal end of the separated swg measured approximately 343 mm and the length of the proximal end of the separated swg measured approximately 256 mm.This brings the total length of the separated swg to 599 mm, which is within specification; therefore, no pieces appear to be missing.The outer diameter of the guide wire was also within specification.(con't) other remarks: a manual tug test confirmed both welds are intact.A device history record review was performed and no relevant findings were identified.The instructions-for-use provided with this kit describes suggested techniques to minimize the likelihood of guide wire damage during use.It warns 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.The report that the guide wire was separated was confirmed through examination of the returned sample.The swg was separated 343 mm from the distal end of the swg (256 mm from the proximal end).Both the distal and proximal welds were intact; however, the core wire protruding from each separated piece was curved and rounded.This indicates that the swg likely separated due to contact with a needle bevel.The swg body also contained multiple kinks and the coil wire was unraveled at the point of separation.The swg met relevant dimensional requirements and 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.No further action will be taken.

Event Description

The customer reports the guide is in poor condition because it was deformed when passing it and when it was removed it was split.The device was replaced and a delay was reported without issue.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7450472
• MDR Text Key: 106263240
• Report Number: 9680794-2018-00084
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: CV-15703
• Device Lot Number: 14F17J0367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Date Manufacturer Received: 05/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR