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	02/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer reference: (b)(4).The device has been received but not yet evaluated.The event is currently under investigation.
Event or Problem Description
It was reported that treatment against chronic total occlusion (cto) lesion in the right superficial femoral artery (sfa) was performed by right common femoral artery approach, using an advance 14 lp low profile balloon catheter.When the physician dilated the cto lesion in the sfa, near popliteal artery with the complaint balloon, it ruptured.The device was replaced with another manufacturer's balloon and the procedure was completed successfully.The direction of the rupture was unknown.The patient's condition was reported as recovered.
Additional Manufacturer Narrative
Evaluation: a review of complaint history, device history record, documentation, drawing, ifu, quality control, specifications; and a visual inspection of the complaint device was conducted for the purpose of this investigation.One used advance 14 lp low profile balloon catheter was returned to assist with the evaluation.A complaint history search revealed this complaint to be the only reported complaint associated to the complaint lot number.A device history record for complaint lot was review and noted no non-conformance related to related to the alleged device failure.A device failure analysis reveals the device exhibited no damage and the balloon was able to be inflated.The length and diameter of the balloon measured within specifications.There is no evidence to suggest the product was not manufactured to current specifications.There is no evidence to suggest all items in the lot or similar devices in the field are nonconforming or defective.Therefore, based upon the information provided and the characteristics displayed, it is plausible to suggest that this incident was user handling related.The failure was unable to be duplicated.At this time, a definitive root cause could not be determined.The root cause of this complaint is inconclusive.We will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.

• 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: 6450096
• Report Number: 1820334-2017-00503
• Device Sequence Number: 587994
• Product Code: DQY
• UDI-Device Identifier: 10827002503288
• UDI-Public: (01)10827002503288(17)180206(10)5636283
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2017

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: PTAX4-14-170-3-4
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/03/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/31/2017
• Supplement Report FDA Received Date: 04/24/2017; 05/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1