MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW TRAUMA SET: 7 FR; INTRODUCER, CATHETER

Catalog Number RC-09700

Device Problem Entrapment of Device (1212)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

Qn# (b)(4).Potential lot# 14f19d0018.Attempts made to obtain additional information from user facility.No response from user facility at the time of this report.A dhr was conducted on the potential lot# and there were no relevant findings.

Event Description

Medwatch 0502280000-2019-8002 received in (b)(6) on november 7, 2019.Report indicates: a procedure by anesthesiologist was performed: insertion of a rapid infusion catheter into the left upper extremity using a guidewire.The patency of the ic was checked by ultrasound and flushed with saline.The following day, an ex-ray the following confirmed the guidewire was retained and was seen in the left arm running along the left sided thoracic spine.The patient was taken to interventional radiology for removal.Page 4 of medwatch indicates other information about the patient that may have influenced the outcome of the event was that they had difficulty in establishing iv access.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The event of the guide wire being left in the patient was likely caused by the user inadvertently leaving the guide wire when removing the dilator.The ifu provided with this kit instructs the user to remove the guide wire and dilator as a unit.However, without subjecting the actual sample to dimensional and functional testing, the probable root cause could not be determined.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Medwatch (b)(4) received in morrisville on november 7, 2019.Report indicates: a procedure by anesthesiologist was performed: insertion of a rapid infusion catheter into the left upper extremity using a guidewire.The patency of the ic was checked by ultrasound and flushed with saline.The following day, an ex-ray the following confirmed the guidewire was retained and was seen in the left arm running along the left sided thoracic spine.The patient was taken to interventional radiology for removal.Page 4 of medwatch indicates other information about the patient that may have influenced the outcome of the event was that they had difficulty in establishing iv access.

• Brand Name: ARROW TRAUMA SET: 7 FR
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9363111
• MDR Text Key: 171592132
• Report Number: 9680794-2019-00464
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• PMA/PMN Number: K840455
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RC-09700
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/07/2019
• Initial Date FDA Received: 11/22/2019
• Supplement Dates Manufacturer Received: 11/22/2019
• Supplement Dates FDA Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR