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

Model Number	N/A
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
During a fistulogram procedure the advance 35 lp low profile balloon was placed through tight stenosis in the axillary vein.Upon placement, the balloon was inflated and consequently, ruptured circumferentially.Upon withdrawing the device, a portion of the balloon remained in the patient.Attempts were made to remove balloon fragments, but these attempts were unsuccessful.The patient was admitted to the hospital to remove the balloon fragments through an open procedure occurring (b)(6) 2017.Physician was unconcerned with migration of the fragmented balloon due to thrombus.Additional information has been requested about the patient's condition after surgery, however, no information has been returned at this time.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, drawings, instructions for use (ifu), specifications and quality control of the device was 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.Review of device history record shows 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 and results of the investigation, a definitive root cause to the reported event could not be conclusively determined.Without benefit of visual, dimensional, or functional testing of the product any manufacturing related issues could not be identified.Clinical factors that may have contributed; however, may be related to operational context of the device in conjunction with the patient's preexisting condition of a tight, stenotic lesion in the axillary vein.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
It was reported that during a fistulagram procedure the advance 35 lp low profile balloon was placed through a very tight, stenotic lesion in the axillary vein.There was no angulation or calcium present.Upon inflation, the balloon ruptured circumferentially.During withdrawal of the device, a portion of the balloon was reported to have remained in the patient.The medical team's attempts at removal of the balloon fragments were unsuccessful; however, the treating physician was reported to be unconcerned with migration due to the fact that the balloon fragments were located within thrombus.The patient was subsequently admitted to the hospital for a removal procedure scheduled for (b)(6) 2015.Further information was provided that the patient's dialysis graft was working.There was uncertainty regarding where the fragment ended up.Of note, the type of contrast used for the procedure was isovue 300 at a ratio of 3:1 with sodium chloride (nacl).Balloon pressure at the time of rupture was unknown.

• 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: 6424026
• Report Number: 1820334-2017-00554
• Device Sequence Number: 16278015
• Product Code: DQY
• UDI-Device Identifier: 10827002523613
• UDI-Public: (01)10827002523613(17)191129(10)7474279
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/10/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PTA5-35-80-8-8.0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2017
• Supplement Report FDA Received Date: 05/10/2017
• 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: Hospitalization; Required Intervention