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

Catalog Number	PTA5-35-80-9-4.0
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the initial reporter, the device will not be returned.(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 during an unspecified vascular procedure, the advance 35 lp low profile balloon catheter ruptured.Access was gained from the femoral artery (fa) to treat the severely calcified lesion of the common iliac artery (cia).During treatment, the balloon ruptured at 4 to 8 atmospheres (atm).There was no angulation.It is not known what type of contrast was used or what the mix of contrast to saline was.The initial reporter did not know if the balloon ruptured circumferentially or longitudinally.The procedure was completed using another device.According to the initial reporter, 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.
Additional Manufacturer Narrative
Investigation ¿ evaluation.A review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), quality control, specifications, and a visual inspection of the returned representative devices were conducted during the investigation.The actual complaint device was not returned for evaluation.The visual inspection of the returned devices noted no defects or damage.All three devices were inflated to rated burst pressure, and none of the devices burst.The balloons were found to measure within manufacturing specifications.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 representative products, 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.Investigation ¿ evaluation.A review of the complaint history, device history record, documentation, drawing, instructions for use (ifu), quality control, specifications, and a visual inspection of the returned representative devices were conducted during the investigation.The actual complaint device was not returned for evaluation.The visual inspection of the returned devices noted no defects or damage.All three devices were inflated to rated burst pressure, and none of the devices burst.The balloons were found to measure within manufacturing specifications.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 representative products, 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.

• 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: 7454621
• Report Number: 1820334-2018-01133
• Device Sequence Number: 10995715
• Product Code: DQY
• UDI-Device Identifier: 10827002523668
• UDI-Public: (01)10827002523668(17)200725(10)8090700
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2018

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: PTA5-35-80-9-4.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 05/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1