MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number	N/A
Medical Device Problem Code	Sticking (1597)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The reported device has been received, an evaluation is in progress.
Event or Problem Description
It was reported, during a peripheral lower leg case, the advance 18 lp low profile balloon catheter was being removed over a v18 boston scientific wire, and the balloon became stuck, as if the wire was sticky.The wire and balloon had to be removed from the patient together.Also during the procedure, a rubicon crossing catheter was used with an abbott wire and the same difficulty occurred.The procedure was completed and the patient remained unharmed.The user facility reported they were unsure what caused the devices to become stuck and why the wire became sticky.No additional details have been received.
Additional Manufacturer Narrative
Evaluation narrative: a review of the complaint history, device history record, quality control, and visual inspection of the returned device was conducted during the investigation.Review of the device history record shows the finished goods lot 4726410 passed all the inspections and product specifications satisfactorily.There were no other reported complaints for this lot number.Instructions are in place to verify that the device is manufactured to specification.One used advance 18 lp low profile balloon catheter with a wire guide stuck in the balloon was returned for evaluation.No visual damage to the catheter was noted.The balloon was inflated with 15cc of air using a 20cc syringe and no damage was noted to the balloon.The wire guide that was stuck in the catheter has an outer diameter of.0176".A definitive root cause could not be determined.Per the risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• Brand Name: ADVANCE 18 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: 6349154
• Report Number: 1820334-2017-00285
• Device Sequence Number: 579661
• Product Code: DQY
• UDI-Device Identifier: 10827002502373
• UDI-Public: (01)10827002502373(17)170101(10)4726410
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K073378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PTA4-18-135-5-4
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/25/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2017
• Supplement Report FDA Received Date: 04/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR