MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number	PTA4-18-80-6-20
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); Occlusion (1984)
Date of Event	05/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol cap008, complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.Blank fields on this form that have not been previously submitted indicate the information is unknown or unavailable.
Event or Problem Description
The complainant reported that the advance 18 lp low profile balloon catheter was advanced across a calcified lesion and inflated to 8 atm (atmospheres) without any problems.An angiogram displayed occlusion of the left sfa (superficial femoral artery) and popliteal vessel.The balloon was then pulled back and inflated for a second time to 8 atm (atmospheres) when the balloon ruptured.The device was successfully removed "otw" and was intact upon removal.The product problem did not result in any reported serious injuries to the patient.

• Brand Name: ADVANCE 18 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: 7747468
• Report Number: 1820334-2018-02385
• Device Sequence Number: 19351922
• Product Code: LIT
• UDI-Device Identifier: 10827002309095
• UDI-Public: (01)10827002309095(17)170501(10)5017016
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/03/2018

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 Expiration Date: 05/01/2017
• Device Catalogue Number: PTA4-18-80-6-20
• Device Lot Number: 5017016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 08/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1