MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW VASCULAR UNKNOWN DUMMY MATERIAL; CATHETER, PERCUTANEOUS

Catalog Number VASCULAR UNKNOWN

Device Problem Migration (4003)

Patient Problems Fever (1858); Necrosis (1971); Sepsis (2067)

Event Date 07/18/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information received: the customer reports the device was in place for six days.After six days the catheter migrated.The patient condition is reported as "critical".The customer cannot rule out if the critical condition was contributed to the reported issue.Tissue necrosis (hand-size) was detected.Currently the necrosis is being treated with necrosis patch.Patient has sepsis.It is unknown if the device is available for evaluation.

Event Description

Customer reported that "cvc slipped through the box clamp (transparent-blue) that the cvc migrated out of patient until 1 cm".

Manufacturer Narrative

Qn# (b)(4).The actual device was not returned; however, the customer did provide two photos for evaluation.The first photo showed a catheter in place secured by a box clamp.The juncture hub was not visible in the photo.The second photo showed padding/bandages on the patient.No conclusions could be drawn from the photos.A device history record review could not be performed as no lot number or material was provided.The ifu for this kit could not be reviewed as the material/lot was not provided by the customer.However, ifu's provided in arrow kits instruct the user, "a catheter clamp and fastener are used to secure the catheter when an additional securement site other than the catheter hub is required for catheter stabilization." complaint verification testing could not be performed as no sample was returned for analysis.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

Customer reported that "cvc slipped through the box clamp (transparent-blue) that the cvc migrated out of patient until 1 cm".

• Brand Name: ARROW VASCULAR UNKNOWN DUMMY MATERIAL
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8869852
• MDR Text Key: 153545010
• Report Number: 1036844-2019-00877
• 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: 07/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: VASCULAR UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 100