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	No Consequences Or Impact To Patient (2199)
Date of Event	01/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510(k) # : k131204.The reported event is currently under investigation.
Event or Problem Description
A treatment of eia lesion was conducted by the ipsilateral groin approach.After the target lesion was pre-dilated with a 35lp(6x20), another manufacturer's stent was placed.After the first inflation, the balloon was deflated and moved to another position in the stent.Upon the second ballooning attempt, a balloon rupture was revealed.The procedure was completed using another 35lp balloon(8x20).The alleged device was used for post dilation of this stent.The patient remained unharmed.No additional details have been received.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, trends, quality control, and visual inspection of the returned device was conducted during the investigation.The work order was reviewed and one non-conformance was noted for damage.The damaged device was scrapped; the work order was marked down and then processed as normal.There were no other reported complaints for this lot number.There is no evidence to suggest this product was not manufactured to specification.The instructions for use (ifu) advise not to exceed rated burst pressure.Over-inflation may cause rupture of the balloon with resultant damage to the vessel wall.The ifu further advise to inspect the catheter upon removal from the package to ensure no damage has occurred during shipping.Photographic inspection of the returned device confirmed that the balloon burst longitudinally.The root cause could not be determined.The device has been archived at the manufacturing facility.Monitoring will be conducted for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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: 6301213
• Report Number: 1820334-2017-00110
• Device Sequence Number: 550100
• Product Code: DQY
• UDI-Device Identifier: 10827002523514
• UDI-Public: (01)10827002523514(17)170801(10)5179180
• Combination Product (Y/N): N
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2017

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: PTA5-35-80-7-2.0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/05/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/03/2017
• Supplement Report FDA Received Date: 06/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1