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

Catalog Number RC-09700

Device Problem Material Separation (1562)

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

Event Date 10/02/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports a case of a retained wire while attempting to place a ric.There is no patient injury or consequence.The patient condition is reported as "fine".There are no patient complications or injury.Therapy was reported to be delayed/interrupted.Additional information: the thought is that the guide wire was lost while placing the ric line.It was found to be in the patient the next day (when the patient had an x-ray) and required an additional procedure (with ir) to remove it.It was removed successfully.

Event Description

The customer reports a case of a retained wire while attempting to place a ric.There is no patient injury or consequence.The patient condition is reported as "fine".There are no patient complications or injury.Therapy was reported to be delayed/interrupted.Additional information: the thought is that the guide wire was lost while placing the ric line.It was found to be in the patient the next day (when the patient had an x-ray) and required an additional procedure (with ir) to remove it.It was removed successfully.

Manufacturer Narrative

(b)(4).The sample was not returned for evaluation; however, the sales rep provided one photo for investigation.The photo was of the lidstock which provided the lot number and material number.The defect in the spring wire guide could not be confirmed through the photo.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit warns the user "do not apply excessive force in removing guide wire, dilator or sheath.If withdrawal cannot be easily accomplished, an x-ray should be obtained and further consultation requested." complaint verification testing could not be performed as no sample was returned for analysis and the provided photo was of only the lidstock.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.

• Brand Name: ARROW TRAUMA SET: 7 FR
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9213592
• MDR Text Key: 177960628
• Report Number: 9680794-2019-00408
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/08/2019

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: No Information
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: RC-09700
• Device Lot Number: 14F19D0018
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 11/08/2019
• Supplement Dates FDA Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention