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

Model Number	N/A
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
Two advance 35 lp low profile balloon catheters were used in the right leg for peripheral arterial occlusive disease.It was reported that after the first balloon was placed it was unable to be inflated using an inflation device.The balloon was exchanged for a new one, however, the second balloon was also unable to be inflated.A third balloon was used and the procedure was able to be completed without issue.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.
Additional Manufacturer Narrative
Investigation - evaluation: a review of documentation, manufacturing instructions, instructions for use, complaint history, device history record, dimensional verification, specifications, and quality control data, and visual inspection of the returned devices was conducted during the investigation.Visual inspection and functional testing of the returned devices were performed.Device 1: no visible damage is noted to the catheter shaft.A pinhole leak is noted.Crow¿s feet were not present, however balloon is not able to inflate or hold pressure due to a pinhole leak.Bio-material is present.Device 2: no visible damage was noted to the catheter shaft.The balloon is not able to be inflated.It is noted that a longitudinal burst is present.Crow¿s feet were not present, however balloon was not able to inflate and hold pressure due to the longitudinal burst.Bio-material is present inside the balloon.Both devices met dimensional requirements for balloon and catheter length.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the information provided, and the results of our investigation, a definitive root cause could not be determined.Measures have been previously initiated to address this issue.We will notify the appropriate personnel and continue to monitor for similar complaints.

• 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: 6842828
• Report Number: 1820334-2017-02740
• Device Sequence Number: 18962438
• Product Code: DQY
• UDI-Device Identifier: 10827002523415
• UDI-Public: (01)10827002523415(17)190212(10)6731765
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2017

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: No Information
• Device Model Number: N/A
• Device Catalogue Number: PTA5-35-80-5-10.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/31/2017
• Supplement Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 09/05/2017
• Supplement Report FDA Received Date: 11/29/2017
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Weight: 76