MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS KIT: 2-L 14 FR X 20 CM ANTI; CATHETER, HEMODIALYSIS, NON-I

Model Number	IPN035502
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
The complaint is reported as: guidewire inserted smoothly and after 10cm it would not advance further so they attempted to remove the guidewire but it got stuck in the introducer.The guidewire was kinked and broken.
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.Corrected data: section f.10 and h.6.-health effect impact code corrected to 2199 section f.10 and h.6.-health effect clinical code corrected to 4582.
Event or Problem Description
The complaint is reported as: guidewire inserted smoothly and after 10cm it would not advance further so they attempted to remove the guidewire but it got stuck in the introducer.The guidewire was kinked and broken.Additional information was received indicating that medical intervention was not necessary and there was no harm to the patient.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 14 FR X 20 CM ANTI
• Common Device Name: CATHETER, HEMODIALYSIS, NON-I
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12061496
• Report Number: 1036844-2021-00129
• Device Sequence Number: 19783417
• Product Code: MPB
• UDI-Device Identifier: 00801902068002
• UDI-Public: 00801902068002
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K993933
• 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): 06/08/2021

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: No Information
• Device Expiration Date: 12/31/2021
• Device Model Number: IPN035502
• Device Catalogue Number: CDC-25142-X1A
• Device Lot Number: 23F20J0234
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 07/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1