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

Model Number	N/A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This event is currently under investigation.
Event or Problem Description
First the stenosis was dilated with enforcer 6mm in diameter with a sub-optimal result.Attempt to dilate with a 7mm pta balloon (pta4-18-80-7-2).The balloon was inflated up to 20 atm at which pressure the balloon burst.While retrieving the balloon through the sheath the balloon got stuck to the sheath.Heavy force was applied to remove the balloon.Physician succeeded in removing the balloon, but the distal part of the balloon was completely stretched and the distal part of the balloon was only still there because it was on the terumo wire guide.Inspection of the balloon revealed that the balloon had ruptured in the wrong direction.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.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control and visual inspection of the returned device was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use, specific items are addressed such as: do not exceed rated burst pressure (14 atm/bar).Rupture of balloon may occur.Adhere to balloon inflation pressure parameters in the compliance card insert.Over-inflation may cause rupture of the balloon, with resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures.The burst pressure data was analyzed using factors for a one-sided tolerance to determine with 95% confidence that 99.9% of these balloons would not burst below the calculated rated burst pressure.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.The affected product was returned to assist in the investigation.The balloon catheter appears lodged on to the wire guide, likely due to excess force used to remove the catheter.The balloon shows signs of a longitudinal split and a circumferential separation.The proximal portion of the balloon measures 1.8 cm in length while the distal portion measures 1.5 cm in length.Additionally, the distal portion of the balloon has been inverted.There is no evidence to suggest that this balloon was not manufactured to specifications.It was reported that this balloon was inflated to 20atm.This is above the rated burst pressure listed in the compliance card insert and package label.The root cause of this failure mode can be attributed to off-label use of the product.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
First the stenosis was dilated with enforcer 6mm in diameter with a sub-optimal result.Attempt to dilate with a 7mm pta balloon.The balloon was inflated up to 20 atm; at which pressure the balloon burst.While retrieving the balloon through the sheath, the balloon got stuck to the sheath.Heavy force was applied to remove the balloon.The physician succeeded in removing the balloon, but the distal part of the balloon was completely stretched and the distal part of the balloon was only still there because it was on the terumo wire guide.An inspection of the balloon revealed that the balloon had ruptured in the wrong direction.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.

• 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: 5761611
• Report Number: 1820334-2016-00562
• Device Sequence Number: 8692
• Product Code: DQY
• UDI-Device Identifier: 10827002502540
• UDI-Public: (01)10827002502540(17)170929(10)5318032
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K073378
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2016

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: PTA4-18-80-7-2
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/08/2016
• Device Age: 22 MO
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2016
• Supplement Report FDA Received Date: 11/15/2016
• 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: Other