MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PSI SET: 8.5 FR; INTRODUCER, CATHETER

Model Number	IPN033183
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
The complaint is reported as: "incompetent valve.Blood keeps pouring out from the dilator.The doctor says, no harm was done to the patient.She rewired the sheath without incident." no patient injury or consequence reported.The patient's condition is reported as fine.
Event or Problem Description
The complaint is reported as: "incompetent valve.Blood keeps pouring out from the dilator.The doctor says, no harm was done to the patient.She rewired the sheath without incident." no patient injury or consequence reported.The patient's condition is reported as fine.
Additional 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 PSI SET: 8.5 FR
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12327905
• Report Number: 9680794-2021-00408
• Device Sequence Number: 4301347
• Product Code: DYB
• UDI-Device Identifier: 00801902011206
• UDI-Public: 00801902011206
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K780532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

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: 02/28/2026
• Device Model Number: IPN033183
• Device Catalogue Number: IC-09880
• Device Lot Number: 14F21B0243
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1