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	08/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, or unavailable.(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
An advance 35 lp low profile balloon catheter was used for endovascular treatment (evt) of a non-calcified lesion in the left superficial femoral artery (sfa).Access to the sfa was gained by ipsilateral approach from the left groin.It was reported, after a 0.035 inch wire guide passed through the lesion, the balloon was advanced over it and dilation of the lesion was started.However, when the physician applied 6 atm of pressure, the balloon ruptured.Another catheter was used to complete the procedure.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 the complaint history, dimensional verification, device history record, instructions for use (ifu), manufacturing instructions, specifications, trends, quality control, and visual inspection of the returned device was conducted during the investigation.One advance 35 lp low profile balloon catheter was returned for investigation.No damage was noted to the catheter shaft.Inspection of the balloon noted a 2.7cm longitudinal rupture was present.Crows feet did not appear to be present, however bio-material was present.Length of catheter and balloon were both within specifications.Proximal and distal bonds showed no non-conformities.A document-based investigation was performed.Review of the device history record shows nonconforming events; however, all nonconformance's have been reworked or scrapped before the lot was processed as normal.There were no other reported complaints for this lot number.Based on the information provided, examination of the returned product, and the results of our investigation; a definitive root cause could not be determined.Measures have been 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: 6824982
• Report Number: 1820334-2017-02757
• Device Sequence Number: 1041372
• Product Code: DQY
• UDI-Device Identifier: 10827002523514
• UDI-Public: (01)10827002523514(17)180227(10)5682985
• Combination Product (Y/N): N
• PMA/510(K) Number: K091527
• 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,Followup
• Report Date (Section B): 12/01/2017

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: PTA5-35-80-7-2.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/24/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 08/28/2017
• Supplement Report FDA Received Date: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1