MAUDE Adverse Event Report: COVIDIEN (IRVINE) CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number 104-4770

Device Problem Burst Container or Vessel (1074)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/14/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not received for analysis.However, when the device is received a supplemental will be submitted.The lot history record of the reported lot number has been reviewed and no quality issues were noted.

Event Description

Medtronic received report that during the procedure, the hyperform balloon ruptured within the treating vessel.The patient was reported to be undergoing a selective catheterization of the right internal carotid artery (ica), a right internal carotid arteriogram, and cerebral arteriography.The surgeon was reported to have placed the hyperform balloon in the internal carotid proximal to the aneurysm with no issue.The balloon was inflated and then reported to have ruptured within the vessel.The patient was not injured and the procedure was aborted, as there were no other balloons to complete the procedure.The treatment was rescheduled for the following day.It was also reported that the device was not tested prior to use.The device was not noticed to have been damaged prior to the rupture.

Manufacturer Narrative

The hyperform balloon catheter was returned for analysis with the guidewire was protruding from the hub.The total and working length of the balloon catheter were measured to be within specifications.The guidewire was removed from within the catheter with slight resistance.The guidewire was found to be bent at ~1.5cm from the distal end.The guidewire distal solder tip was found to be corroded.Due to the damaged condition of the guidewire it could not be used for further testing.The balloon catheter was flushed with water and found patent.An in-house guidewire was inserted into and through the catheter lumen to test for inflation.An attempt to inflate the balloon was unsuccessful as it was found to be leaking distal of the distal marker band.Upon examination, a defect (tear) in the chronoprene tubing was found at the location of the leak.No ruptures were found.No other anomalies were observed.The lot history record review of the reported lot number showed no discrepancies that would have contributed to the reported experience.Based on the device analysis the customers report was confirmed.The device evaluation showed the balloon could not maintain inflation due to the defect (tear) in the chronoprene tubing.The cause of the damage could not be determined as the device was not test prior to use in the patient.However, the defect observed is consistent with pinholes caused by mechanical damage or during navigation rather than those caused by over-inflation (rupture).

• Brand Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Type of Device: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 5401624
• MDR Text Key: 37241232
• Report Number: 2029214-2016-00055
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2016

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: 08/02/2017
• Device Model Number: 104-4770
• Device Catalogue Number: 104-4770
• Device Lot Number: A1416810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2016
• Initial Date FDA Received: 02/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 00064 YR