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 12/10/2013

Event Type  malfunction  

Event Description

The complaint received states that during prep the ascent balloon catheter 6 mm x 9 cm (brs00060900 / c14069) ruptured.Even though the operating staff followed ifu exactly, ascent balloon blew during the prep to use.There was no report of injury for the patient.No patient or vessel code information provided.

Manufacturer Narrative

Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

The complaint received states that during prep the ascent balloon catheter 6 mm x 9 cm (brs00060900 / c14069) ruptured.Even thought, the operating staff followed ifu exactly, ascent balloon blew during the prep to use.There was no difficulty removing the device from the hoop.The device prepped normally.There is no information regarding contrast media used.Normal contrast ration of 1:1 was used.A syringe device was used to prep and inflate.There was no reported resistance/friction, the event occurred during prep.The balloon inflated normally during prep; however, then burst.No patient or vessel code information provided.There was no report of injury for the patient.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.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.

Manufacturer Narrative

The complaint received states that during prep the ascent balloon catheter 6 mm x 9 cm ((b)(4)) ruptured.Even though, the operating staff followed ifu exactly, ascent balloon blew during the prep to use.There was no difficulty removing the device from the hoop.The device prepped normally.There is no information regarding contrast media used.Normal contrast ration of 1:1 was used.A syringe device was used to prep and inflate.There was no reported resistance/friction, the event occurred during prep.The balloon inflated normally during prep; however, then burst.No patient or vessel code information provided.There was no report of injury for the patient.Conclusion: complaint is not confirmed.Even though the issue described in the event description is balloon burst, no radial or longitudinal tear was found as a result of the visual inspection conducted.The issue identified from this product complaint is: a pinhole in the balloon area.The investigation showed a pinhole in the balloon area as a result of an inflation test executed.Water instead of contrast media was used for the inflation test.As soon as the water reached the balloon area a jet of water was seen.A prior investigation revealed that one of the possible failures when the balloon is over inflated 1 mm above its label diameter is the occurrence of a pinhole leak.(see (b)(4) report part 2).The length between balloon proximal seal and the balloon distal seal for this returned unit is approximately 17 mm.This is an indication that the balloon was over inflated which resulted in stretching the balloon and possibly led to rupture, no additional damage around the pinhole was observed.The root cause of this product complaint appears to be balloon over inflation.All the causes identified are discarded since 100% leak testing is performed on each balloon catheter before it is released to determine whether the balloon leaks, so it is no likely that the balloon left codman neurovascular with this type of failure.No issues related to this product complaint were found in the dhr review executed for this lot# c14069.The reported balloon rupture was not confirmed; however, there was a confirmed pin hole leak on the balloon.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.

• 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; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: denise singleton ; miami lakes, FL 33014 ; 4084331514
• MDR Report Key: 3590390
• MDR Text Key: 16912072
• Report Number: 1226348-2014-00016
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K080861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/26/2013

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: 02/11/2014
• Device Catalogue Number: BRS00060900
• Device Lot Number: C14069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/19/2014
• Initial Date FDA Received: 01/24/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/03/2014; 05/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• 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