MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Catalog Number	PTAX4-14-170-2-2
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the initial reporter, the device will not be returned.(b)(4).This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that during treatment of a restenosis lesion of the patient's superficial femoral artery (sfa) (stent had been previously placed), the thrombus moved to the popliteal artery.Thrombus aspiration was performed, however it was unsuccessful.The physician attempted to utilize the advance 14 lp low profile balloon catheter to press the thrombus against the popliteal arterial wall while inflating to pressure of eight (8) atmosphere (atm); however, the balloon ruptured.Another cook medical 14 lp balloon catheter of a different size (2x40 centimeter length) was used to successfully complete the procedure.It was noted that the patient's arteries were calcified, and angulation in the popliteal artery was present as the thrombus was located at the trifurcation.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, device history record, instructions for use (ifu), manufacturing instructions, quality control, specifications, trends, and a visual inspection and functional evaluation of the returned representative device were conducted during the investigation.The inspection of the returned device confirmed that it could be successfully inflated.There were no signs of damage on the returned balloon; however, a leak was detected from the metal segment of the catheter, at a distance of 80.7 cm from the proximal end.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned representative product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment, no further action is required.

• 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: 7236923
• Report Number: 1820334-2018-00341
• Device Sequence Number: 1028658
• Product Code: DQY
• UDI-Device Identifier: 10827002503134
• UDI-Public: (01)10827002503134(17)190219(10)6747912
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K090822
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2018

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 Catalogue Number: PTAX4-14-170-2-2
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 05/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1