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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/29/2018
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
An unused, unopened representative device was received by the manufacturer for investigation of an event previously reported under report reference number (b)(4).Upon examination, the representative device was found to have a leak.The device never made patient contact; therefore, no adverse effects were reported.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.A review of the complaint history, device history record, documentation, drawing, manufacturing instructions, quality control, specifications, and a visual inspection and functional evaluation of the returned representative device were conducted during the investigation.The actual complaint device was not returned.The representative device was unopened.The visual inspection of the returned device confirmed the presence of a leak in the metal segment of catheter, at a distance of 80.7 cm from proximal end of the device.The representative device was successfully inflated, and the balloon showed no signs of damage.Additionally, a document based investigation evaluation was performed.A review of the device history record showed two nonconforming events which could contribute to this failure mode; however, due to the individual nature of the product manufacturing and 100% verification of various defects, including inspection of the shaft and leak testing in final quality control prior to shipping, there is no indication that there is nonconforming product in the field.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned 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.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 7502932
• Report Number: 1820334-2018-01356
• Device Sequence Number: 123700
• Product Code: DQY
• UDI-Device Identifier: 10827002503134
• UDI-Public: (01)10827002503134(17)190219(10)6747912
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2018

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 Catalogue Number: PTAX4-14-170-2-2
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/25/2018
• Supplement Date Received by Manufacturer: 08/08/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 08/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1