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

Model Number	N/A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be submitted upon completion.
Event or Problem Description
It is alleged that an advance 35 lp low profile balloon catheter was being used for an endoscopic third ventriculostomy procedure when the balloon ruptured.It was reported that a wire guide passed through the lesion successfully, as did the balloon catheter, as the patient's anatomy was said to have some calcifications, but nothing severe.The complainant claims that as the physician attempted to inflate the balloon, however, it failed.The balloon catheter was removed, and allegedly the balloon device exhibited a longitudinal rupture.It was reported that another manufacturer's balloon was then used to successfully complete the procedure.No adverse events have been reported regarding this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation : a review of the complaint history, device history record, documentation, drawing, instructions for use, specifications, and quality control data was conducted during the investigation.The complaint device was not returned, therefore physical examination of the device by the quality engineering and/or engineering departments could not be performed.A review of the device history record shows one nonconforming event that is relevant to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned, and the results of our investigation; a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.We will notify the appropriate personnel and continue to monitor for similar complaints.
Event or Problem Description
An international customer reported a rupture of an advance 35 lp low profile balloon catheter balloon during an endovascular treatment (evt) of the right external iliac artery (eia), which was performed by ipsilateral approach from the right common femoral artery.Contrast to saline mix of 4:6 omnipaque contrast:water was used.The stenosis and calcification in the lesion was not severe.Further information was provided that there was no angulation or vessel calcification; the ¿patient¿s anatomy was suitable for the procedure.¿ after a wire guide was passed through the lesion without problems, the complaint balloon catheter was successfully placed at the locus of the lesion over a non-cook 0.035 wire guide.Then, the physician attempted to start the pre-dilation, but the balloon would not inflate.It was retrieved out of the body and checked; longitudinal rupture in the balloon was confirmed.Another manufacturer's 5mm balloon was used instead without problems.A 9mm 35pta balloon was used for post-ballooning, which had no issues and the procedure was completed.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• 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: 6741993
• Report Number: 1820334-2017-01873
• Device Sequence Number: 13769936
• Product Code: DQY
• UDI-Device Identifier: 10827002523385
• UDI-Public: (01)10827002523385(17)180226(10)5678693
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2017

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: N/A
• Device Catalogue Number: PTA5-35-80-5-4.0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/11/2017
• Supplement Date Received by Manufacturer: 07/26/2017
• Initial Report FDA Received Date: 07/25/2017
• Supplement Report FDA Received Date: 08/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1