MAUDE Adverse Event Report: MEDTRONIC, INC. RAPID CROSS PTA CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	A14BX025210170
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Vascular surgery procedure medtronic rapid cross pta balloon dilation catheter used device broke apart inside patient all pieces retrieved no harm to patient.

• Brand Name: RAPID CROSS PTA CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 17218728
• Report Number: MW5118892
• Device Sequence Number: 17906818
• Product Code: LIT
• UDI-Device Identifier: 00763000110871
• UDI-Public: 00763000110871
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/23/2023

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 Model Number: A14BX025210170
• Device Catalogue Number: A14BX025210170
• Device Lot Number: B408393
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2023
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White