MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW EXT DWELL CATH DEVICE 20GAX6CM; CATHETER INTRAVASCULAR THERAPE

Model Number IPN037859

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/04/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: during removal, the catheter separated in patient's right forearm after 20 days insitu and a piece of the catheter was retained in the patient's vein.Patient was taken to the operating room for right forearm exploration witn removal of foreign body.The catheter was removed from the patient and ultrasound confirmed no evidence of catheter or foreign body was seen.The patient tolerated the operation with no complications and was transferred to the pacu in stable condition.The operative notes state: "we circumferentially dissected the vein and performed a small venotomy to remove the catheter.Unfortunately the catheter was adhered to the vein wall.We then transected the vein and pulled the catheter out in it's entirety.We re-evaluated the forearm with ultrasound and there was no evidence of a catheter or foreign body seen.".

Event Description

The complaint is reported as: during removal, the catheter separated in patient's right forearm after 20 days insitu and a piece of the catheter was retained in the patient's vein.Patient was taken to the operating room for right forearm exploration with removal of foreign body.The catheter was removed from the patient and ultrasound confirmed no evidence of catheter or foreign body was seen.The patient tolerated the operation with no complications and was transferred to the pacu in stable condition.The operative notes state: "we circumferentially dissected the vein and performed a small venotomy to remove the catheter.Unfortunately the catheter was adhered to the vein wall.We then transected the vein and pulled the catheter out in it's entirety.We re-evaluated the forearm with ultrasound and there was no evidence of a catheter or foreign body seen.".

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.

• Brand Name: ARROW EXT DWELL CATH DEVICE 20GAX6CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11859731
• MDR Text Key: 251824310
• Report Number: 9680794-2021-00242
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10801902132908
• UDI-Public: 10801902132908
• Combination Product (y/n): N
• PMA/PMN Number: K151513
• 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: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: IPN037859
• Device Catalogue Number: EDC-00620
• Device Lot Number: 14F21A0167
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR