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

Model Number	G52255
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/05/2018
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, the advance 35 lp low profile balloon catheter burst circumferentially.During an unspecified below-the-knee procedure, the physician inflated the complaint device to nominal pressure using a contrast /saline mixture.There was no angulation of the unspecified vessel; however, heavy calcification was present.The complaint device reportedly ruptured immediately after inflation.The procedure was successfully completed using another cook balloon without any adverse effects to the patient.A section of the device did not remain inside the patient¿s body.
Additional Manufacturer Narrative
Investigation ¿ evaluation.A review of the dimensional verification, complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, trends, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The device was inspected, and biomatter was noted on the device.An initial attempt to inflate the device failed.As a result, the device was stored in decontamination liquid for two days.Upon removal, the balloon was able to inflate.During a visual inspection of the device, a pinhole leak was detected and photographed in the area of the proximal marker band.No additional non-conformities of the device were noted.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 the lot was released meeting all finished goods release criteria.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.

• 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: 7722169
• Report Number: 1820334-2018-02110
• Device Sequence Number: 11151349
• Product Code: DQY
• UDI-Device Identifier: 10827002522555
• UDI-Public: (01)10827002522555(17)200918(10)8223539
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2018

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: 09/18/2020
• Device Model Number: G52255
• Device Catalogue Number: PTA5-35-135-4-12.0
• Device Lot Number: 8223539
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6FR TERUMO-SCHLEUSE
• Patient Age: 79 YR