MAUDE Adverse Event Report: COOK INCORPORATED ADVANCE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	G34372
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
We had a cook balloon that was placed into the patient and the external piece not in the patient broke and we were able to remove the balloon.

• Brand Name: ADVANCE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 15612124
• Report Number: 15612124
• Device Sequence Number: 6518972
• Product Code: LIT
• UDI-Device Identifier: 10827002343723
• UDI-Public: (01)10827002343723(17)2502512(30)1(10)CINC001479
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2022
• Report Date (Section F): 09/29/2022

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: G34372
• Device Catalogue Number: PTA5-35-80-9-2.0
• Device Lot Number: CINC001479
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/14/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/14/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 89 KG
• Date Report Sent to FDA: 09/29/2022