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

Model Number	IPN037859
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
The complaint is reported as: inserter accessed vessel, engaged the guidewire without incident, and then began to advance the catheter over the guidewire.Inserter met resistance and pulled catheter back over needle.Catheter was sheared.Ir (interventional radiology) was consulted.Catheter tip retrieved by cutdown.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided five (5) photos for evaluation.Visual examination of the photos confirmed the catheter body appeared cut and separated.The point of separation visible in the photos appeared smooth, which is damage consistent with contacting a sharp object (i.E.Needle bevel).A device history record review was performed and no relevant findings were identified.The instructions-for-use provided with this kit cautions the user, "do not attempt to advance needle back into catheter after catheter is partially threaded off needle to reduce risk of catheter damage." the customer reported that "inserter said she met resistance and pulled catheter back over needle" which caused the catheter to shear.This statement indicates the user did not follow the ifu.The customer report of a cut/separated catheter was confirmed by visual examination of the customer supplied photos.The visible edges of separation appeared consistent with being cut by a sharp object (i.E.Needle bevel).A device history record review was performed with no relevant findings.The ifu states, "do not attempt to advance needle back into catheter after catheter is partially threaded off needle to reduce risk of catheter damage." the customer explicitly stated that the catheter was pulled back over the needle.Based on the appearance of the damage and the customer report, intentional use error caused or contributed to this issue by not following the ifu.An in-service has been requested to further educate the customer on the intended use.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
The complaint is reported as: inserter accessed vessel, engaged the guidewire without incident, and then began to advance the catheter over the guidewire.Inserter met resistance and pulled catheter back over needle.Catheter was sheared.Ir (interventional radiology) was consulted.Catheter tip retrieved by cutdown.The patient's condition is reported as fine.

• Brand Name: ARROW EXT DWELL CATH DEVICE 20GAX6CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11447372
• Report Number: 9680794-2021-00098
• Device Sequence Number: 14463262
• Product Code: FOZ
• UDI-Device Identifier: 10801902132908
• UDI-Public: 10801902132908
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K151513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

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
• Operator of Device: No Information
• Device Expiration Date: 11/30/2022
• Device Model Number: IPN037859
• Device Catalogue Number: EDC-00620
• Device Lot Number: 14F20M0053
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention