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

Model Number	N/A
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	03/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Investigation ¿ evaluation a review of the complaint history, device history record, documentation, instructions for use (ifu), quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the presence of a clear, crystallized substance inside the balloon.No damage was observed on both the surfaces of the balloon and the catheter.A leak was present between the strain relief and the hub, but the balloon itself was not leaking.No cracks were present at the hub, and the correct hub was used.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.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.Measures have been previously conducted to address this failure mode.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
The international customer reported that, during a percutaneous transluminal angioplasty of tibial arteries, the balloon would not stay inflated.The balloon was removed and tested outside of the patient, at which time an air leakage from the balloon was confirmed.A contralateral technique was taken during the procedure.It was reported that there was some calcification and normal anatomy in the tibial artery.The device was replaced, and the angioplasty was continued for another hour with no adverse effect on the patient.
Additional Manufacturer Narrative
(b)(4).Review of the device history record of the finished product shows one nonconforming event that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.
Event or Problem Description
The international customer reported that during a percutaneous transluminal angioplasty of tibial arteries, the balloon would not stay inflated.The balloon was removed and tested outside of the patient, at which time an air leakage from the inflation hub connector was confirmed.A contralateral technique was taken during the procedure.It was reported that there was some calcification and normal anatomy in the tibial artery.The device was replaced, and the angioplasty was continued for another hour with no adverse effect on the patient.

• 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: 6730950
• Report Number: 1820334-2017-02050
• Device Sequence Number: 1038589
• Product Code: DQY
• UDI-Device Identifier: 10827002503257
• UDI-Public: (01)10827002503257(17)191102(10)7410479
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K090822
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PTAX4-14-170-2.5-16
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/21/2017
• Supplement Date Received by Manufacturer: 07/14/2017
• Initial Report FDA Received Date: 07/21/2017
• Supplement Report FDA Received Date: 08/02/2017
• 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: 75 YR
• Patient Weight: 57