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

Model Number	G52360
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
User occupation: lab manager.A follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported, during an angioplasty of the superficial femoral artery, the advance 35 lp low profile balloon catheter ruptured.The balloon was introduced to the patient through a 6 fr cook sheath.Reportedly, the patient's anatomy did not contain angulation or vessel tortuosity; however, severe calcification was noted.Approximately 80% of the target lesion was occluded.The balloon device was inflated a total of 3 times to 10 atmospheres for roughly 1 minute each time using a sphere inflation device.The first inflation was in the stent, and the following two were outside of the stent, with the third causing the circumferential rupture.The balloon was never removed and reinserted after the initial access.The ruptured balloon became stuck on calcification, and could not be retrieved through the sheath.It was at this time that the patient was taken to the or for a surgical removal of the balloon device.Additional information regarding patient outcome has been requested, but is not available at this time.
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), manufacturer¿s instructions, quality control procedures, and specifications of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 did reveal one nonconforming event which could potentially relate to this failure mode.It should be noted, however, that the identified item was scrapped and not replaced.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, specifications, drawing, and quality control procedures were conducted, and no gaps were discovered.An ifu is provided with this device, which warns ¿do not exceed rated burst pressure.Rupture of balloon may occur.Adhere to balloon inflation pressure parameters in the compliance card insert.Over-inflation may cause rupture of the balloon, with resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures.¿ it goes on to say, ¿the catheter is not intended for the delivery of stents.¿ based on the information provided and no product returned, investigation has concluded that this event could not be traced to the device, but to the patient¿s condition and the procedure.Reportedly, the device was first inflated inside a stent, contrary to the precautions of the ifu.Additionally, it is also possible that the patient¿s anatomy contributed to this incident as it was reported that the patient¿s anatomy was severely calcified, and the ruptured balloon became caught on calcification and subsequently separated.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Measure are being taken to address this failure mode.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: 9198700
• Report Number: 1820334-2019-02624
• Device Sequence Number: 3146748
• Product Code: DQY
• UDI-Device Identifier: 10827002523606
• UDI-Public: (01)10827002523606(17)220131(10)9488290
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2019

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: 01/31/2022
• Device Model Number: G52360
• Device Catalogue Number: PTA5-35-80-8-6.0
• Device Lot Number: 9488290
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 12/13/2019
• 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