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

Model Number	G35532
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2015
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
During an angiogram of the femoral artery, the physician placed the stent and inflated then deflated the balloon.Upon removing the balloon it partially detached from the catheter and then got caught on the sheath.The physician was able to remove the entire device from the patient.The physician was finished with this procedure so no additional devices were required.There was an unspecified amount of blood but no transfusion was required.No additional procedures or intervention required due to this occurrence.

• 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: 6706704
• Report Number: 1820334-2017-01888
• Device Sequence Number: 832292
• Product Code: LIT
• UDI-Device Identifier: 10827002355320
• UDI-Public: (01)10827002355320(17)180224(10)5672052
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• 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: G35532
• Device Catalogue Number: PTA5-35-135-5-20.0
• 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