MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW RA CATH SET: 20 GA X 1-3/4"; WIRE GUIDE CATHETER

Catalog Number RA-04020

Device Problem Unraveled Material (1664)

Patient Problems Hematoma (1884); No Known Impact Or Consequence To Patient (2692)

Event Date 07/15/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: product passed pre-use check but when wire was being withdrawn after blood flash it started to uncoil inside the patient.Patient had a hematoma after the line was removed.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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

The customer reports: product passed pre-use check but when wire was being withdrawn after blood flash it started to uncoil inside the patient.Patient had a hematoma after the line was removed.

• Brand Name: ARROW RA CATH SET: 20 GA X 1-3/4"
• Type of Device: WIRE GUIDE CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10345080
• MDR Text Key: 202088231
• Report Number: 9680794-2020-00317
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K810675
• 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: 07/17/2020

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: No Information
• Device Catalogue Number: RA-04020
• Device Lot Number: 14F19H0371
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 07/30/2020
• Supplement Dates Manufacturer Received: 08/20/2020
• Supplement Dates FDA Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1