MAUDE Adverse Event Report: COOK MEDICAL / COOK, INC. ADVANCE 35LP LOW PROFILE PTA BALLOON DILATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Lot Number	CINC001108
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Cook medical advance 35lp low profile pta balloon dilation catheter ruptured during use.

• Brand Name: ADVANCE 35LP LOW PROFILE PTA BALLOON DILATION CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK MEDICAL / COOK, INC.
• MDR Report Key: 18121651
• Report Number: MW5148040
• Device Sequence Number: 18071288
• Product Code: LIT
• UDI-Device Identifier: 10827002523590
• UDI-Public: (01)10827002523590(17)250322(30)1(10)CINC001108
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/07/2023

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 Expiration Date: 03/22/2025
• Device Lot Number: CINC001108
• 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: 11/09/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Female