MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Catalog Number	PTAX4-14-170-2.5-4
Health Effect - Clinical Code	Calcium Deposits/Calcification (1758)
Date of Event	12/04/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
The complainant reported tortuosity in the vessels below the knee and a severely calcified lesion.The advance 14 lp low profile balloon catheter was advanced from the left groin to the severely calcified and tortuous lesion.However, the device could not pass through the lesion.As a result, pre-dilation was performed with another manufacturer's balloon.The other manufacturer's device could not pass through the lesion either.A third manufacturer's balloon was then used to pass through the lesion and complete the procedure.It was further noted that the catheter was gouged/cut.There were no reported serious injuries to the patient as a result of the product problem.

• Brand Name: ADVANCE 14 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7602053
• Report Number: 1820334-2018-01808
• Device Sequence Number: 1799395
• Product Code: DQY
• UDI-Device Identifier: 10827002503219
• UDI-Public: (01)10827002503219(17)171230(10)5548123
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2018

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 Catalogue Number: PTAX4-14-170-2.5-4
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1