MAUDE Adverse Event Report: COOK INC ADVANCE 14 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	02/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The reported device has been received, an evaluation is in progress.
Event or Problem Description
It was reported during an unspecified procedure the advance 14 lp low profile balloon catheter ruptured.There was severe calcification in the lesion.The device was advanced over another manufacturer's 0.014 inch wire guide from the left groin to the left sfa ipsilaterally.While inflating the advance 14 lp low profile balloon catheter, the balloon ruptured before reaching the nominal pressure.The direction of the rupture of the balloon is unknown.Another manufacturer's device was used to complete the procedure.There was no adverse effect to the patient reported.No additional details have been received.
Additional Manufacturer Narrative
A review of the complaint history, device history record, instructions for use, manufacturing instructions, quality control, trends and a visual inspection of the complaint device was conducted.One advance 14 lp low profile balloon catheter was returned for investigation.The length of the catheter is 166.0 cm.No damage is noted.Balloon length is 3.8 cm.The diameter of the balloon is 0.14291 in.Balloon was able to be inflated and no leak was detected.It is unknown why the customer experienced difficulty.It is plausible to suggest that patient condition may have made manipulation of the balloon catheter difficult during the procedurally related event.A definitive root cause could not be determined.A review of the device history file indicate that the device was manufactured and packaged according to specifications.There is no evidence to suggest the product was not manufactured to current specifications.We will continue to monitor for similar complaints.

• Brand Name: ADVANCE 14 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: 6420847
• Report Number: 1820334-2017-00443
• Device Sequence Number: 474577
• Product Code: DQY
• UDI-Device Identifier: 10827002503356
• UDI-Public: (01)10827002503356(17)180918(10)6217517
• Combination Product (Y/N): N
• PMA/510(K) Number: K090822
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2017

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: PTAX4-14-170-4-4
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/20/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2017
• Supplement Report FDA Received Date: 04/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1