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

Model Number	G52260
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2018
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, during an antegrade right femoral angioplasty procedure, the advance 35 lp low profile balloon catheter ruptured.The procedure was successfully completed using another balloon catheter.The patient's anatomy was neither tortuous nor calcified.No patient adverse effects have been reported.Additional information regarding event details, patient anatomy and outcome has been requested, but is not available at this time.
Additional Manufacturer Narrative
Device available for evaluation: yes.Concomitant medical products: 6 french sheath, boston amplatz wire, boston inflation handle.Additional information was received from the customer.Multiple attempts to cross the lesion were made, and the inflation diameter of the balloon was gradually increased in an attempt to open up a tract.The complaint device inflated a few times prior to the rupture.It was confirmed that the device was inflated to a working pressure of 8 atmospheres, and the contrast to saline ratio employed was 40/60.The lesion was located at the superficial femoral artery, and there was no angulation; however, the vessel was very calcified.The balloon reportedly burst longitudinally.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
Additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
A review of the dimensional verification, complaint history, device history record, instructions for use (ifu), manufacturing review, quality control, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the presence of a pinhole leak in the balloon, which leaked air upon the inflation of the device.The pinhole was noted to be a distance of 4.5 cm from the distal end (in approximately the middle of the balloon).A kink was noted a length of 1.2 cm from the proximal end.Measuring from proximal end, compressions were noted from a length of 10.5 cm to 11.0 cm, 23.4 cm to 23.8 cm, 47.9 cm to 48.2 cm, 54.5 cm to 54.8 cm, and 78.9 cm to 79.2 cm.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.Measures are being conducted to address this failure mode.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 investigation findings.

• 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: 7639021
• Report Number: 1820334-2018-01698
• Device Sequence Number: 13841726
• Product Code: DQY
• UDI-Device Identifier: 10827002522609
• UDI-Public: (01)10827002522609(17)201004(10)8266117
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K091527
• 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,Followup
• Report Date (Section B): 08/16/2018

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 Expiration Date: 10/04/2020
• Device Model Number: G52260
• Device Catalogue Number: PTA5-35-135-5-8.0
• Device Lot Number: 8266117
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 06/27/2018; 08/14/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 07/20/2018; 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1