MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW VESSEL CATH KIT: 20GA X 5"; CATHETER, PERCUTANEOUS

Catalog Number AK-04550-S

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Tissue Damage (2104)

Event Date 05/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: physicians complain that the straight soft tip end of the guide-wire is not soft enough.In one instance, during line insertion into a radial artery the wire proved to be a hindrance the tip is too stiff and has caused a number of dissections as reported by physicians.Due to this the patient received radial artery damage.The patient condition is reported as fine and healing normal.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Physicians complain that the straight soft tip end of the guide-wire is not soft enough.In one instance, during line insertion into a radial artery the wire proved to be a hindrance the tip is too stiff and has caused a number of dissections as reported by physicians.Due to this the patient received radial artery damage.The patient condition is reported as fine and healing normal.

• Brand Name: ARROW VESSEL CATH KIT: 20GA X 5"
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7540161
• MDR Text Key: 109114267
• Report Number: 3003737899-2018-00063
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: AK-04550-S
• Device Lot Number: 13F17L0314
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1