MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number	G50265
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(b)(4).A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during a procedure to re-dilate an existing unknown stent in the right pulmonary artery involving a male pediatric patient of unspecified age, an advance 18 lp low profile balloon catheter ruptured circumferentially and separated upon removal.An unknown 8 french sheath and unknown wire guide were utilized during the procedure.The balloon was inflated once inside the stent to 10 atmospheres with a 1:3 ratio of lopamirol contrast to saline.There was no reported angulation, tortuosity, or calcification.The balloon and sheath were removed as a unit, over a wire guide, while performing a counterclockwise rotation of the balloon.There was no blood observed inside of the unknown inflation device.An open surgical procedure was performed to remove the separated portion of the balloon from the patient.
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
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.Reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), quality control procedures, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one used pta4-18-80-8-2 separated into two pieces was returned to cook for investigation.The proximal segment included the hub which was attached to 77cm of the strain relief and attached to the strain relief was 1.5cm of balloon material.The distal piece consisted of 2cm of balloon material with 8cm of tip material from the balloon bond to the tip.A small piece of wire was stuck inside the distal segment.The middle part of the balloon was not returned.On the distal separated piece, the balloon material contained both a longitudinal and circumferential tear.The longitudinal tear started 7mm from the distal balloon bond.There were no marker bands present on the device.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.Furthermore, reviews of the manufacturer¿s instructions, drawing, specifications, and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with this device, which states all the appropriate precautions, warnings, indications, and contraindications.Based on the information provided and the examination of the returned product, investigation has concluded that this event could not be traced to the device but to the procedure.The physician reported ¿maybe the crowns of the stent are the reason of the bursting of the balloon¿.Measure are being taken to address this failure mode.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 18 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: 9030246
• Report Number: 1820334-2019-02306
• Device Sequence Number: 2155930
• Product Code: DQY
• UDI-Device Identifier: 10827002502656
• UDI-Public: (01)10827002502656(17)220408(10)9649571
• Combination Product (Y/N): N
• PMA/510(K) Number: K073378
• 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): 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/08/2022
• Device Model Number: G50265
• Device Catalogue Number: PTA4-18-80-8-2
• Device Lot Number: 9649571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention