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

Model Number	G52353
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant products: viabahn covered stent, 7x10 boston scientific sheath, boston scientific inflation device (b)(4).This report includes information known at this time.A follow-up report will be submitted at the conclusion of the investigation or, when additional relevant information becomes available.
Event or Problem Description
It was reported, a (b)(6) year old male on hemodialysis was undergoing a fistulogram of a vein in the left upper arm to angioplasty a ninety percent stenosis.No calcification, angulation, or tortuosity was present.An advance 35 lp low profile balloon catheter was inflated in the stenosis one atmosphere above burst pressure when the balloon ruptured circumferentially.This was the initial inflation.Other devices in use at the time were another manufacturer's 7x10 sheath and inflation device.Visipaque contrast was used but the ratio of saline to contrast was not provided.Blood was noted in the inflation device.The balloon was not inflated inside a stent prior to rupture.A 7x4 balloon was advanced into the venous system.The balloon was inflated, and pulled pieces back into the sheath (reference fogarty technique).Another manufacturer's covered stent was placed due to the severity of the venous stenosis and not as a result of the balloon rupturing.All pieces of the balloon were able to be removed successfully.There was no patient adverse effect.
Additional Manufacturer Narrative
Investigation - evaluation: reviews of the complaint history, device history record, drawing, instructions for use (ifu), manufacturer¿s instructions, quality control, 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 showed one nonconforming event which could contribute to this failure mode.This nonconformance was for bond damage.While this could potentially be related to the reported failure, it should be noted that the affected unit was scrapped and not replaced prior to order completion.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufacturer¿s instructions, drawing, and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with this device, which states "inflate balloon to desired pressure.Adhere to recommended balloon inflation pressures.If balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit." based on the information provided and no product returned, investigation has concluded that this event can be traced to the user and a failure to follow instructions.Reportedly, the user exceeded the rated burst pressure.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.
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: 8616521
• Report Number: 1820334-2019-01201
• Device Sequence Number: 11307728
• Product Code: DQY
• UDI-Device Identifier: 10827002523538
• UDI-Public: (01)10827002523538(17)220401(10)9632291
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2019

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: 04/01/2022
• Device Model Number: G52353
• Device Catalogue Number: PTA5-35-80-7-6.0
• Device Lot Number: 9632291
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 07/05/2019
• 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
• Patient Age: 68 YR