MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number	G52270
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 a peripheral angioplasty, the advance 35 lp low profile balloon catheter was not inflated due to leakage at the proximal end of the balloon.Another balloon catheter was used to successfully complete the procedure.A section of the device did not remain inside the patient¿s body.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, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control, functional testing, and visual inspection of the returned device was conducted during the investigation.One used advance 35 lp low profile balloon catheter was returned for evaluation.A leak test was performed with water.When the balloon was inflated, a pinhole was found on the proximal end of the balloon.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Numerous design verification and validation activities have been performed to ensure that this device meets design requirements.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Each device is shipped with ifu which outline intended use, contraindications, warnings, precautions, and potential adverse events.Based on the information provided and the results of our investigation, a definitive root cause cannot be determined at this time, however appropriate measures have been initiated to address this failure mode.A risk assessment was performed, and the appropriate personnel have been notified.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: 7183635
• Report Number: 1820334-2018-00127
• Device Sequence Number: 10793842
• Product Code: DQY
• UDI-Device Identifier: 10827002522708
• UDI-Public: (01)10827002522708(17)200811(10)8134212
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2018

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 Model Number: G52270
• Device Catalogue Number: PTA5-35-135-6-14.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/08/2018
• Supplement Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 03/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1