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

Model Number	G52300
Medical Device Problem Codes	Kinked (1339); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2018
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 after opening the package while flushing the advance 35 lp low profile balloon catheter with saline prior to dilatation of iliac vein, a kink was observed on the push rod.The device did not come into contact with the patient.Another device was utilized to successfully complete the procedure.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Upon manufacturer receipt and review of provided imaging, it was noted that the device appears to be stretched.
Additional Manufacturer Narrative
Investigation evaluation: a review of the complaint history, device history record, documentation, drawing, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the presence of accordion damage, which was noted between 9.1 cm and 10.3 cm from the distal end of the device (the tubing portion under the balloon).Kinks were noted at lengths of 81.0 cm, 112.3 cm, and 112.7 cm from the proximal end.A stress mark 1.1 cm in length was noted to begin at a length of 112.3 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 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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.Refer to section h10 for investigational findings.
Additional Manufacturer Narrative
Additional information was received from the customer regarding the reported incident.The customer confirmed that there was no damage to the packaging of the device.Upon opening the package and flushing the balloon, the previously reported kink mark of the push rod was discovered.The operator continued to use the device, although a slight resistance was felt when the operator pushed the wire through the balloon.Furthermore, it was difficult to push the balloon through the sheath; as a result, the operator removed both the balloon and the wire from the sheath.This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• 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: 7330969
• Report Number: 1820334-2018-00669
• Device Sequence Number: 1630554
• Product Code: DQY
• UDI-Device Identifier: 10827002523002
• UDI-Public: (01)10827002523002(17)201030(10)NS8332061
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2018

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: G52300
• Device Catalogue Number: PTA5-35-135-12-8.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 05/03/2018; 06/14/2018
• Initial Report FDA Received Date: 03/12/2018
• Supplement Report FDA Received Date: 05/25/2018; 06/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 46