MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Catalog Number	PTAX4-14-170-3-20
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/05/2018
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 14 lp low profile balloon catheter unraveled.While preparing the complaint device for use during an endovascular therapy procedure of a chronic totally occluded superficial femoral artery, the physician had difficulty removing the shipping stylet from the catheter's lumen.He used a hemostat device to try to remove it and was successful after applying more force to the hemostat.With the wire guide already inserted in the patient's anatomy, the complaint device was being advanced when it became stuck on the wire guide.The complaint device did not make patient contact.After removal, the advance 14 lp low profile balloon catheter appeared elongated and was replaced with another manufacturer's balloon catheter to successfully complete the procedure.No patient adverse effects were reported.Although a kink was not noted, the physician questioned if a kink could have been present making it difficult to remove the stylet initially.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
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: it was reported that the stylet of the device was pulled out through the distal tip as usual.Investigation ¿ evaluation.A review of the dimensional verification, complaint history, device history record, drawing, instructions for use (ifu), manufactures instructions, quality control, specifications, and a functional test & visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the orange shipping stylet stopper was lodged in the lumen 35.7cm from the distal end and was 6mm in length.The stylet was 51.9cm in length and has a diameter of.01593 inches.A 6mm section of the distal tip was damaged from the distal end.During the functional test, the stylet was easily inserted until it connected with the stylet stopper.The distal marker band was 8mm from the distal end and was against the distal segment of balloon.The balloon¿s overall length and the diameter were measured, and both measurements were within specification.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 was one other reported complaints for this lot number and it was opened to address a difficult advancement over a wire guide.This event was a separate procedure.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 ¿remove the stylet and protective balloon sleeve from balloon.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be established.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 14 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: 7971208
• Report Number: 1820334-2018-03154
• Device Sequence Number: 16516052
• Product Code: DQY
• UDI-Device Identifier: 10827002503332
• UDI-Public: (01)10827002503332(17)210806(10)9070368
• Combination Product (Y/N): N
• PMA/510(K) Number: K090822
• 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): 01/30/2019

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: 08/06/2021
• Device Catalogue Number: PTAX4-14-170-3-20
• Device Lot Number: 9070368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Initial Date Received by Manufacturer: 10/05/2018
• Supplement Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 10/16/2018
• Supplement Report FDA Received Date: 01/30/2019
• 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: WIRE GUIDE (MANUFACTURER UNKNOWN).