MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Model Number	IPN914754
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that "once the guide was inserted, the anesthesiologist felt a roughness when he was advancing it.He then decided to withdraw the needle, but the doctor felt a resistance to the withdrawal, as did the guide, so he withdrew the needle and the guide at the same time.The patient experienced severe pain during this removal but fortunately no clinical consequences.When the guide was removed, it was stretched and distended in places (a "telephone cord" structure that was very close and rigid).".
Additional Manufacturer Narrative
(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 or Problem Description
It was reported that "once the guide was inserted, the anesthesiologist felt a roughness when he was advancing it.He then decided to withdraw the needle, but the doctor felt a resistance to the withdrawal, as did the guide, so he withdrew the needle and the guide at the same time.The patient experienced severe pain during this removal but fortunately no clinical consequences.When the guide was removed, it was stretched and distended in places (a "telephone cord" structure that was very close and rigid).".

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 13529345
• Report Number: 3006425876-2022-00161
• Device Sequence Number: 11772149
• Product Code: DQY
• UDI-Device Identifier: 10801902158007
• UDI-Public: 10801902158007
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2022

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 Expiration Date: 06/30/2025
• Device Model Number: IPN914754
• Device Catalogue Number: CV-17702
• Device Lot Number: 71F21A0436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2021
• 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
• Patient Sex: Unknown