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 08/17/2015

Event Type  malfunction  

Manufacturer Narrative

The product will be returned for analysis, but it has not been received to date.Additional information will be submitted within 30 days of receipt.Concomitant medical products and therapy dates:.014¿xpedion wire (details unknown).Ten cc syringe (details unknown).Septor microvention balloon (details unknown).(b)(4).

Event Description

It was reported by the hospital contact that the balloon (brs00060900/c24840) burst on the back table.The balloon was being prepared on back table before bto (balloon test occlusion) exam started.Wire port of device was flushed with saline and.014"xpedion wire (details unknown) was advanced through lumen out end of balloon.A 90% contrast (omnivue300) and 10% saline mixture was used in a separate mixture cup.A 10cc syringe (details unknown) with mixture 5-6cc's was drawn up and and a negative withdraw was done on balloon port (to remove any air).Then the balloon was prepped with mixture holding balloon upright.A small bubble was seen in balloon as it filled with contrast/saline mixture.Attempts were made to get bubble to top and out vent hole.As balloon filled bubble was at top while trying to get drip of mixture out top of vent hole pressure was applied and balloon burst on back table.The physician said he thought small air bubble was still in balloon at time of rupture and they did not see weep or drip of contrast that is why they applied more pressure.At no time did balloon enter the patient.A septor microvention balloon (details unknown) was used in place of this.The product will be returned for analysis.There was no clinically significant delay in the procedure due to the event.

Manufacturer Narrative

It was reported by the hospital contact that the balloon (brs00060900/c24840) burst on the back table.The balloon was being prepared on back table before bto (balloon test occlusion) exam started.Wire port of device was flushed with saline and.014¿xpedion wire (details unknown) was advanced through lumen out end of balloon.A 90% contrast (omnivue300) and 10% saline mixture was used in a separate mixture cup.A 10cc syringe (details unknown) with mixture 5-6cc¿s was drawn up and and a negative withdraw was done on balloon port (to remove any air).Then the balloon was prepped with mixture holding balloon upright.A small bubble was seen in balloon as it filled with contrast/saline mixture.Attempts were made to get bubble to top and out vent hole.As balloon filled bubble was at top while trying to get drip of mixture out top of vent hole pressure was applied and balloon burst on back table.The physician said he thought small air bubble was still in balloon at time of rupture and they did not see weep or drip of contrast that is why they applied more pressure.At no time did balloon enter the patient.A septor microvention balloon (details unknown) was used in place of this.The product will be returned for analysis.There was no clinically significant delay in the procedure due to the event.Issues identified from the event description: balloon burst on the back table.Visual inspection: 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 dry contrast media was noted outside and inside of the balloon catheter area.Functional inspection: catheter flushed appropriately.Balloon was ruptured, so the balloon could not be inflated.Conclusion: complaint was not confirmed.The presence of dry contrast media outside and inside the balloon area didn¿t allow observing the balloon rupture.A couple of balloon inflation attempts were performed using water, the water couldn¿t reach the balloon.The dry contrast media inside doesn¿t allowed it.One of the causes that may have led to this effect (balloon burst) is the mentioned air bubble that could not be pulled out from the balloon.Air bubbles in the balloon 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 with dry contrast media outside and inside the balloon area which made not possible confirms it is burst.It is not possible to investigate causes such as whether the vent hole is opened 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 or there is dry contrast media inside the balloon obstructing it¿s capacity to be inflated.All the causes identified in regards to the catheter are discarded since 100% leak testing is performed on each balloon catheter before it is released to determine whether the vent hole is opened and whether or not the balloon leaks, so it is no likely that the balloon left codman neurovascular with the vent hole closed.Therefore, no corrective actions will be taken 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: kimberly soter ; 325 paramount dr; raynham, MA 02767 ; 5089777396
• MDR Report Key: 5148023
• MDR Text Key: 28202967
• Report Number: 1226348-2015-00051
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/18/2015

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: 03/31/2016
• Device Catalogue Number: BRS00060900
• Device Lot Number: C24840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1