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

Model Number	G52254
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/22/2018
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 treatment of femoral artery occlusions of the patient's lower extremities, the advance 35 lp low profile balloon catheter could not be inflated.The physician advanced the balloon through the calcified artery to the target site.After discovering the complaint device would not inflate, it was withdrawn.A split was found in the balloon.A 6 french sheath was being utilized during the procedure.Subsequently, the complaint device was changed for a new balloon catheter and the procedure was successfully completed.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
Investigation ¿ evaluation.A review of the dimensional verification, complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control, specifications, 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 one balloon pinhole, which was found at the distal end of the balloon, and appeared to be directly over the distal marker band.Fifteen pointed protrusions were also noted on the catheter shaft (between lengths of 74.9 cm and 91.7 cm from the proximal end), along with a flattened area extending from a length 80.6 cm to 91.6 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.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
Additional information regarding the event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Additional information: b5: during preliminary visual inspection of the returned device, rough, pointed protrusions were noted on the surface of the device.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: 7686640
• Report Number: 1820334-2018-02021
• Device Sequence Number: 1315887
• Product Code: DQY
• UDI-Device Identifier: 10827002522548
• UDI-Public: (01)10827002522548(17)210504(10)8862696
• 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,use
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2018

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: 05/04/2021
• Device Model Number: G52254
• Device Catalogue Number: PTA5-35-135-4-10.0
• Device Lot Number: 8862696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 08/03/2018; 08/14/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 08/10/2018; 08/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1