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)
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
An advance 35 lp low profile balloon catheter was used post icast stent placement, within the common iliac artery.It was reported that when the physician released negative pressure on the device, there was blood in the tubing indicating the balloon had ruptured.Another device was used to successfully 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, device history record, documentation, drawing, instructions for use (ifu), specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One used advance 35 lp pta balloon catheter was returned for evaluation and examined.An attempt was made to inflate the balloon and leakage was detected.A pinhole leak was noted approximately 4.0cm from the distal tip.The balloon did not rupture.The length of the catheter measured within specifications.A document-based investigation was performed.There is no evidence to suggest the finished product is not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.There were no other reported complaints for this lot number.Numerous design verification and validation activities have been performed to ensure that this device meets design requirement.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements, and that the device meets the needs of the user.Each device is shipped with instructions for use (ifu) listing the indications for use, contraindications, warnings and precautions, and the correct deployment procedure.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.There is no evidence the product was damaged upon opening.According to the customer, there was stenosis of plaque noted in the vasculature.Per the ifu, "the balloon is manufactured from an extra-thin wall, high-strength, minimally-compliant material.Particular care should be taken in handling the balloon to prevent damage." also, per the ifu, "¿choose a balloon appropriate to lesion length and vessel diameter.Upon removal from package, inspect the catheter to ensure no damage has occurred during shipping." therefore, based upon the information provided and the characteristics displayed, it is plausible to suggest the root cause of this event was human anatomy related.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed 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: 6918784
• Report Number: 1820334-2017-03467
• Device Sequence Number: 16474753
• Product Code: DQY
• UDI-Device Identifier: 10827002523668
• UDI-Public: (01)10827002523668(17)200710(10)8050538
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2017

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: PTA5-35-80-9-4.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/28/2017
• Supplement Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1