MAUDE Adverse Event Report: COOK INC ADVANCE 35 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	10/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.(b)(4).The event is currently under investigation.
Event or Problem Description
The balloon ruptured circumferentially.Upon pulling the balloon out, pieces of the balloon were left inside the patient and had to be removed using a snare.However, one balloon marker had gone down to parenteral, and the user was unable to retrieve this piece.Not flow limiting, therefore the piece remained inside the patient.The procedure was completed with a new device.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the 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 ifu states," particular care should be taken in handling the balloon to prevent damage.Upon removal from package, inspect the catheter to ensure no damage has occurred during shipping.It will inflate to the indicated size parameters when utilizing proper pressure recommendations.Do not exceed rated burst pressure.Rupture of balloon may occur.Over-inflation may cause rupture of the balloon, with result damage to the vessel wall.¿ additionally it states, ¿upon removal from package, inspect the catheter to ensure no damage has occurred during shipping.¿ the affected product was returned to assist in the investigation.Visual inspection noted that the balloon had a longitudinal and circumferential burst.Microscopic examination does not reveal any nonconformance to the balloon.There is no evidence to suggest that the balloon was not manufactured to specifications.A device history record was reviewed and four non conformances were noted.The non-conformances listed were not related to this failure.The results of this investigation are inconclusive.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.Per the 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: 6081711
• Report Number: 1820334-2016-01229
• Device Sequence Number: 2102315
• Product Code: DQY
• UDI-Device Identifier: 10827002523538
• UDI-Public: (01)10827002523538(17)190426(10)6917368
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2017

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: PTA5-35-80-7-6.0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2016
• Supplement Report FDA Received Date: 03/17/2017
• 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: 66 YR