MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC 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 12/05/2014

Event Type  malfunction  

Event Description

Physician opened first ascent during procedure and prepped for use iaw the ifu.While attempting to push contrast out the vent hole, physician noted that the balloon popped before contrast beaded out from the top of the unit.He noted that he had.014 wire in place during the attempted preparation, iaw the ifu.The physician swapped out the balloon for another 6x9 ascent balloon and prepped it without incident.The staff discarded the first balloon so it is unavailable for evaluation.Request overnight replacement of defective first unit.No patient injury resulted.The physician noted that no kinking or damage was evident on the first balloon.Contrast ratio 50/50.Procedure was ¿spinal angio and embo.¿.

Manufacturer Narrative

The product will be return for analysis, but it has not been received.Additional information will be submitted within 30 days of receipt.(b)(4).

Manufacturer Narrative

The labeling guidelines were used to prep the balloon, and no excessive force was used or to prep the balloon.Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

The physician opened first ascent during procedure and prepped for use iaw the ifu.While attempting to push contrast out the vent hole, physician noted that the balloon popped before contrast beaded out from the top of the unit.He noted that he had.014 wire in place during the attempted preparation, iaw the ifu.The physician swapped out the balloon for another 6x9 ascent balloon and prepped it without incident.The staff discarded the first balloon so it is unavailable for evaluation.No patient injury resulted.The physician noted that no kinking or damage was evident on the first balloon.Contrast ratio 50/50.Procedure was ¿spinal angio and embo.¿ the labeling guidelines were used to prep the balloon, and no excessive force was used or to prep the balloon.The ascent balloon was not returned; therefore, the root cause of the event could not be confirmed.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.The device was not returned for analysis, and the event cannot be confirmed.With the information provided it is possible that procedure factors may have contributed to the event.Additionally, 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 taking at this time.

• 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: 4339686
• MDR Text Key: 18086597
• Report Number: 3004107186-2014-10002
• 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,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2015

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: 02/20/2013
• Device Catalogue Number: BRS00060900
• Device Lot Number: F73486
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2015
• Initial Date FDA Received: 12/18/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/14/2015; 02/03/2015
• Date Device Manufactured: 02/21/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR