MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 3-LUMEN 7 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number AK-42703-CDC

Device Problems Break (1069); Difficult to Advance (2920); Migration (4003)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 05/21/2020

Event Type  Injury  

Manufacturer Narrative

Qn # (b)(4).The following additional information was provided by the user facility: on initial placement of cvc, in the subclavian vessel, the user had some difficulty with insertion.A second kit was used , and placement was successful.After insertion the patient was transferred to a higher level of care.This transfer was un-related to cvc placement.A ct scan was ordered (un-related to cvc placement) and it was noted that a fragment of the guide was in a pelvic vessel.A procedure was performed to remove the fragment.Fragment removed without incident.Patient did not experience any complication or change in health status as a result of this event.Hospital stay was not prolonged as a result of this event.

Event Description

The customer reports: unknown to the inserter a broken piece of the wire found post insertion following a transfer to the incoming facility.While it was being placed in a patient the guide wire broke off and migrated to the patient's pelvic vessel.The patient had an additional procedure to remove fragment.Physician had difficulty advancing the catheter on first attempt and aborted and as a result second kit pulled re-accessed with success.Rt subclavian approach second attempt successful.

Manufacturer Narrative

Qn#(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: unknown to the inserter a broken piece of the wire found post insertion following a transfer to the incoming facility.While it was being placed in a patient the guide wire broke off and migrated to the patient's pelvic vessel.The patient had an additional procedure to remove fragment.Physician had difficulty advancing the catheter on first attempt and aborted and as a result second kit pulled re-accessed with success.Rt subclavian approach second attempt successful.

• Brand Name: ARROW CVC KIT: 3-LUMEN 7 FR X 16 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10122790
• MDR Text Key: 194120705
• Report Number: 9680794-2020-00268
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K993691
• 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: 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: AK-42703-CDC
• Device Lot Number: 13F19A0309
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention