MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW ARTERIAL CATH. SET: 20 GA X 8CM; CATHETER, PERCUTANEOUS

Catalog Number SAC-00820-PBX

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the arterial catheter does not work anymore; the arterial curve is not shown on the monitor.Occlusion?.

Manufacturer Narrative

(b)(4).The customer returned one arterial catheter.Signs of use were identified in the form of biological material (dried blood) and sutures on the juncture hub.A kink was identified adjacent to the juncture hub.The catheter body measured 84mm in length, which is within the range of 82 - 86mm specified by the product drawing.A lab inventory syringe was used to inject water into the catheter, but the water did not pass through the distal tip.A lab inventory guidewire was passed through the catheter and dried blood exited the distal tip.Once the obstruction was cleared the catheter aspirated without issue.The lot number was not reported; therefore a device history record review was performed based on a potential lot number from the sales history of the customer.No relevant findings were identified.The instructions-for-use (ifu) that are packaged with this kit provides information on the care and maintenance of an inserted catheter.The customer reported issue of the catheter being obstructed was confirmed during the complaint investigation.The customer returned one used arterial catheter for evaluation.Dimensional inspections was performed and no issues were identified.During initial functional inspection and obstruction was identified, preventing water from passing through the catheter.The obstruction was cleared and identified to be dried blood.After the obstruction was cleared the catheter functioned as intended.A device history record review was performed based on sales history and no relevant findings were identified.Based on the information and sample provided, it was determined that operational context caused or contributed to this event.Teleflex will continue to monitor and trend or reports of this nature.

Event Description

It was reported that the arterial catheter does not work anymore; the arterial curve is not shown on the monitor.Occlusion?.

• Brand Name: ARROW ARTERIAL CATH. SET: 20 GA X 8CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7758251
• MDR Text Key: 116378163
• Report Number: 3006425876-2018-00534
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: SAC-00820-PBX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• Date Manufacturer Received: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1