MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	G35528
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol_(b)(4), compliant/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
The information received indicated that a balloon burst during a percutaneous angioplasty procedure.The lesion was in the superficial femoral artery, described as heavily calcified and a chronic total occlusion.The balloon was delivered to the target lesion and upon initial inflation to 1-2 atmospheres that balloon ruptured.A second balloon was used and the same thing happened.The physician decided to end the procedure and send the patient for bypass surgery.Mdr 1820334-2017-01885 captures adverse event.

• Brand Name: ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6706448
• Report Number: 1820334-2017-01887
• Device Sequence Number: 19149283
• Product Code: LIT
• UDI-Device Identifier: 10827002355283
• UDI-Public: (01)10827002355283(17)180714(10)6030257
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/12/2017

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: G35528
• Device Catalogue Number: PTA5-35-135-4-6.0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2017
• Initial Report FDA Received Date: 07/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1