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

Model Number	G52264
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, an advance 35 lp low profile balloon catheter ruptured between 4 and 5 atmospheres (atm) due to heavy calcification in the distal superficial femoral artery (sfa).Slight angulation of the vessel was reported.Visipaque 320 contrast was used in a 50/50 mix with saline.The angioplasty procedure was successfully completed with another device of the same type.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.
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 dimensional verification, complaint history, device history record, instructions for use (ifu), manufactures instructions, quality control, trends, and a visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device confirmed that the catheter was smooth, clean, and not damaged.The length of the balloon catheter measured within specification.A 2.1cm longitudinal rupture was noted in the balloon.No other nonconformances were noted with the device.Due to the rupture accurate measurements of the balloon length and diameter could not be obtained.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.Furthermore, a review of the manufactures instructions and quality control procedures was conducted, and no gaps were discovered.Moreover, an ifu is provided with the device, which states ¿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." how supplied: "store in a dark, dry cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred." it goes on to say, ¿if resistance is met while advancing the balloon dilation catheter, determine the cause and proceed with caution.¿ based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be traced to the device, but may lie with the patient¿s condition has heavy calcification was noted.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.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 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: 7976607
• Report Number: 1820334-2018-03108
• Device Sequence Number: 1484099
• Product Code: DQY
• UDI-Device Identifier: 10827002522647
• UDI-Public: (01)10827002522647(17)210412(10)8768811
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2019

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 Expiration Date: 04/12/2021
• Device Model Number: G52264
• Device Catalogue Number: PTA5-35-135-6-2.0
• Device Lot Number: 8768811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 12/27/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 01/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 111