MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH KIT: 20 GA X 1 3/4 IN; CATHETER PERCUTANEOUS

Catalog Number	ASK-04020-UV
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported "the wire advanced easily, but the catheter only advanced part way, after which both the wire and catheter were stuck in the patient.The wire was removed however a portion of the catheter remained within the patient." a vascular surgeon was called to fully remove the retained catheter.The patients current condition is reported as "fine".There was no other patient harm or injury.Associated mdr numbers include 9680794-2024-00448.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer report of catheter separated during use was confirmed by visual inspection of the customer supplied photo.However, full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be performed since a correct lot number was not provided by the customer and a potential lot could not be identified from a sales history review.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "the wire advanced easily, but the catheter only advanced part way, after which both the wire and catheter were stuck in the patient.The wire was removed however a portion of the catheter remained within the patient." a vascular surgeon was called to fully remove the retained catheter.The patients current condition is reported as "fine".There was no other patient harm or injury.Associated mdr numbers include 9680794-2024-00448.

• Brand Name: ARROW RA CATH KIT: 20 GA X 1 3/4 IN
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19309869
• Report Number: 9680794-2024-00449
• Device Sequence Number: 11506285
• Product Code: DQY
• UDI-Device Identifier: 10801902215137
• UDI-Public: 10801902215137
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K021120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ASK-04020-UV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown