MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Catalog Number	PTA5-35-80-10-8.0
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported the advance 35 lp low profile balloon catheter ruptured during procedure.No patient adverse effect has been reported.Although requested, it was reported no additional information is available regarding the details of this event.Additionally, the complaint device will not be returned to the manufacturer for investigation.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), manufactures instructions, quality control, and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows one nonconforming event which could contribute to this failure mode.However, that device was scrapped and not replaced.It should be noted there were no other reported complaints for this lot number.With the information provided, no product returned, the results of our investigation, and the root cause of balloon ruptures for similar complaints (which were determined to be from insufficient maintenance and control procedures), the cause for this malfunction can be traced to manufacturing and quality control as there is no additional information that would suggest another conclusion.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ADVANCE 35 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: 7768169
• Report Number: 1820334-2018-02332
• Device Sequence Number: 2050484
• Product Code: DQY
• UDI-Device Identifier: 10827002523750
• UDI-Public: (01)10827002523750(17)210328(10)8698798
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2018

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: 03/28/2021
• Device Catalogue Number: PTA5-35-80-10-8.0
• Device Lot Number: 8698798
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1