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

Catalog Number BRS00060900

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2011

Event Type  malfunction  

Event Description

The complaint received states that during prep the ascent balloon catheter 6 mm x 9 cm (brs00060900 / unk) burst.Balloon was to be used for bto.During prep on back table balloon popped while trying to get to drip from vent hole.They used a contrast ratio of 50/50 optiray 320.20cc syringe used with double negative prep.Another balloon at time and the procedure was completed successfully.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 prep the ascent balloon catheter 6 mm x 9 cm (brs00060900 / unk) burst.Balloon was to be used for bto.During prep on back table balloon popped while trying to get to drip from vent hole.They used a contrast ratio of 50/50 optiray 320.20cc syringe used with double negative prep.Another balloon at time and the procedure was completed successfully.There is no report of injury for the patient.The catheter flushed appropriately.Balloon was ruptured so the balloon could not be tested.The length between the proximal and distal seal was 10mm.This is an indication that the balloon was over inflated which resulted in stretching the balloon and possible led to the rupture.The complaint was confirmed on analysis.100% 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.Review of the information suggests that procedural issues may have contributed to the confirmed event.

Manufacturer Narrative

(b)(4).

• 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: 4075797
• MDR Text Key: 4852225
• Report Number: 1226348-2014-00471
• 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,Followup
• Report Date: 04/25/2011

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 Catalogue Number: BRS00060900
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/25/2011
• Initial Date FDA Received: 09/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• 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