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 01/14/2015

Event Type  malfunction  

Event Description

At initial contact with the customer codman captured that the ascent balloon (brc00041000/c24796) was introduced into the patient and ruptured upon inflation with a 1cc syringe (details unknown).However upon follow up, it was denied that the balloon was ever inserted into the patient.It was noted that the balloon inflated normally during prep on the table.The doctor noted that there was air in the balloon that he was unable to purge during prep.He then deflated the balloon with a 20cc syringe (details unknown).He inflated it again on the table to try to push the air out of the balloon with a contrast/saline mix.At that point the balloon bust.The doctor stated he may have inflated it beyond the stated diameter or rated pressure.0.09cc is the maximum amount of contrast injected.A competitor¿s balloon (details unknown) was used in its place.There were no patient complications.There was no significant clinical delay to the procedure as a result of the issue.There was no difficulty removing the product from the hoop.Isovue 300 contrast media was used with the product.The contrast-to-saline ratio was 50:50.The lesion was not calcified or tortuous.The device was not used for a chronic total occlusion procedure.The device is available for analysis.

Manufacturer Narrative

Concomitant devices: other balloon (details unknown); 1cc syringe (details unknown); 20cc syringe (details unknown); isovue 300 contrast media.The product is available for evaluation and testing, however the analysis has not been completed.Additional information will be submitted within 30 days of receipt.No conclusions are made at this time.

Manufacturer Narrative

As received, the unit was correctly bagged and sealed.No defects were found during the catheter outer surface inspection except on the balloon area where a longitudinal tear of approximately 20 mm from the proximal seal to the distal seal was found.This is an indication that the balloon was over inflated which resulted in stretching the balloon and possibly led to rupture.Catheter flushed appropriately.Balloon was ruptured, so the balloon could not be inflated.The complaint was not confirmed.The investigation showed a longitudinal tear of approximately 20 mm from the proximal seal to the distal seal in the balloon material.One of the causes that may have led to this effect (balloon burst) is the mentioned air bubbles that could not be pulled out from the balloon.Air bubbles in the balloon, per the dfmea, are a consequence of an incorrect preparation of the catheter.After performing the dhr review, for the lot involved on this product complaint, it could be confirmed that there is no anomaly during the manufacturing and inspection processes that can be associated with the reported complaint.The balloon catheter was received from the field burst, it is not possible to investigate causes such as whether the vent hole is open or closed; whether the balloon was over inflated, whether the balloon was not held face up as indicated in the ifu, whether the contrast reached the vent hole prematurely, etc.If the balloon has burst.All possible causes related to a device malfunction are ruled out since 100% leak testing is performed on each balloon catheter before it is released to determine whether the vent hole is open and whether or not the balloon leaks, so it is not likely that the balloon left codman neurovascular with the vent hole closed.Also as there were no anomalies identified during review of the manufacturing documentation for the lot no corrective action will be performed 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: 4513760
• MDR Text Key: 5530011
• Report Number: 3004107186-2015-00001
• 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: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2015

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: 08/31/2015
• Device Model Number: N/A
• Device Catalogue Number: BRC00041000
• Device Lot Number: C24796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2015
• Initial Date FDA Received: 02/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1