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

Model Number	G52344
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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) male weighing (b)(6) with a history significant for hypertension, diabetes, and lower extremity arteriosclerosis and occlusion was undergoing a percutaneous transluminal angioplasty of lower extremity artery procedure using an advance 35 lp low profile balloon catheter.Access was gained via the femoral artery for a contralateral approach utilizing a 6fr sheath (cook).Patient's anatomy was severely calcified and tortuous.During the procedure, the user advanced the balloon catheter along the wire guide (cook) to the lesion, and attempted to inflate it.The atmospheric pressure was reportedly 8 atmospheres (atm) pressure and was increased to 9 atm when the balloon ruptured.This was the second inflation of the complaint device.The first inflation was for 90 seconds and the second inflation was approximately 30 seconds.A mixture of contrast to saline in a 50/50 ratio was used for inflation.Subsequently, the user removed the device and changed to another brand of balloon and finished the procedure.The complaint balloon was removed without the sheath and it was not known if it ruptured circumferentially or longitudinally.It was not inflated inside a stent prior to rupture and was not removed from the body and reinserted prior to the rupture.Blood was noted in the inflation device.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
A review of the dimensional verification, complaint history, device history record, drawing, instructions for use, manufacturing instructions, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed biomatter present throughout the device.A longitudinal split was noted in the balloon material running from the proximal bond to the distal bond.No other damage was noted on the device.While the complaint is confirmed, there is no evidence to suggest that the device was not manufactured to 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 one nonconforming event which could potentially contribute to this failure mode; however, the affected device was scrapped and not replaced.It should be noted there were no other reported complaints for this lot number.The device is packaged with instructions for use, which instructs the user: ¿if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit." furthermore, a review of the manufacturer¿s instructions, drawings, and quality control procedures was conducted, and no gaps were discovered.Based on the information provided, the examination of the returned product, and the results of our investigation, the cause of this event cannot be traced to the device.It is possible that the patient¿s anatomy/condition contributed to the event.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.Measures are being conducted to address this failure mode.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: 8570596
• Report Number: 1820334-2019-00936
• Device Sequence Number: 19265474
• Product Code: DQY
• UDI-Device Identifier: 10827002523446
• UDI-Public: (01)10827002523446(17)210918(10)9170903
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2019

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: 09/18/2021
• Device Model Number: G52344
• Device Catalogue Number: PTA5-35-80-6-2.0
• Device Lot Number: 9170903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2019
• Initial Date Received by Manufacturer: 04/16/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 06/28/2019
• 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: PREVIOUSLY STATED.
• Patient Age: 50 YR
• Patient Weight: 70