MAUDE Adverse Event Report: MICRUS ENDOVASCULAR, LLC ASCENT - BALLOON CATHETER; CES BALLOON CATHETER

Catalog Number BRS00040700

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/30/2011

Event Type  malfunction  

Event Description

The complaint received states that during use the ascent balloon catheter 4 mm x 7 cm (brs00040700 / f61116) burst.Balloon popped during prep on the back table.There is no report of injury for the patient.

Manufacturer Narrative

This mdr is being submitted as part of retrospective review as a result of a recent fda audit and with accordance to the requirements of code of federal regulations ¿ 21 cfr part 803, medical device reporting.The complaint received states that during use the ascent balloon catheter 4 mm x 7 cm (brs00040700 / f61116) burst.Balloon popped during prep on the back table.There is no report of injury for the patient.The product was not returned for evaluation.Without the return of the device; the exact root cause of the problem reported could not be determined.The manufacturing records for this lot were reviewed and did not reveal any relevant discrepancies; design or quality concerns.A search of our field surveillance database yielded no other complaints of this type with this lot.With the information available and without the product available for analysis the complaint could not be confirmed.Inspections are in place to prevent damaged products from leaving the facility and the dhr review confirmed that the product met specifications.No corrective action is required at this time.It is difficult to draw a clinical conclusion between the device and the event based on the limited information available.

• Brand Name: ASCENT - BALLOON CATHETER
• Type of Device: CES BALLOON CATHETER
• Manufacturer (Section D): MICRUS ENDOVASCULAR, LLC; 821 fox lane; san jose CA 95131
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC (SAN JOSE); 821 fox lane; san jose CA 95131
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014 ; 5088283106
• MDR Report Key: 4087661
• MDR Text Key: 4828492
• Report Number: 1226348-2014-00645
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/05/2011

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: 03/31/2012
• Device Catalogue Number: BRS00040700
• Device Lot Number: F61116
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/05/2011
• Initial Date FDA Received: 09/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNK INDEFLATOR