MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW RADIAL ARTERY KIT; WIRE, GUIDE, CATHETER

Model Number	IPN037256
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
Complaint found in maude database: "elderly male with history of hypertension and new onset of chest pain.Having surgery for coronary artery bypass graft, an a line was inserted.During the surgery, the a-line was unable to be flushed or drew back blood.Removed from patient without known harm.".
Additional Manufacturer Narrative
(b)(4).Mdr report key 11235799/mdr text key 228888043/report number 11235799 date report sent to fda 01/22/2021.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
Complaint found in maude database: "elderly male with history of hypertension and new onset of chest pain.Having surgery for coronary artery bypass graft, an a line was inserted.During the surgery, the a-line was unable to be flushed or drew back blood.Removed from patient without known harm.".

• Brand Name: ARROW RADIAL ARTERY KIT
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11414776
• Report Number: 9680794-2021-00081
• Device Sequence Number: 3631623
• Product Code: DQX
• UDI-Device Identifier: 10801902114041
• UDI-Public: 10801902114041
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K810675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: IPN037256
• Device Catalogue Number: ASK-04500-AH
• Device Lot Number: 13F20F0456
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1