MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ASCENT - BALLOON CATHETER; CES BALLOON CATHETER

Model Number N/A

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2015

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Based on the information, the event could not be confirmed.The product was not returned for analysis; however a review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.

Event Description

The contact from the hospital reported that upon balloon prep prior to remodeling of the left internal carotid artery aneurysm, the ascent balloon (brs00040700/c24818) ruptured.It maintained pressure during inflation however it burst upon inflation.No leakage was noted.All steps were followed for balloon prep per the ifu.Another balloon was used to continue the procedure after 5 minutes.However there was no patient injury due to the procedure.There was no difficulty removing the product from the hoop.The contrast to saline ratio was 70:30.A 3cc syringe was used to prep the device.

• Brand Name: ASCENT - BALLOON CATHETER
• Type of Device: CES BALLOON CATHETER
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: duane durbin ; 3260 executive way; miramar, FL 33025 ; 5088288310
• MDR Report Key: 4862780
• MDR Text Key: 22587810
• Report Number: 3004107186-2015-00003
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• PMA/PMN Number: K080861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/03/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: N/A
• Device Catalogue Number: BRS00040700
• Device Lot Number: C24818
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/03/2015
• Initial Date FDA Received: 06/23/2015
• Date Device Manufactured: 12/17/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1