MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC (SUB. OF TELEFLEX INC.) ARROW 5FR. TREROTOLA PTD SET; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number	IPN035902
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Device tip broke off during procedure.Patient needed second surgery to remove the foreign body.Dates of use: (b)(6) 2019 - (b)(6) 2019.

• Brand Name: ARROW 5FR. TREROTOLA PTD SET
• Common Device Name: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): ARROW INTERNATIONAL, INC (SUB. OF TELEFLEX INC.); reading PA 19605
• MDR Report Key: 8337025
• Report Number: MW5084019
• Device Sequence Number: 13498414
• Product Code: MCW
• UDI-Device Identifier: 00801902013156
• UDI-Public: 00801902013156
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2019

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: 09/30/2020
• Device Model Number: IPN035902
• Device Catalogue Number: PT-65509
• Device Lot Number: 13F18J0595
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR