MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR HYPERFORM; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number 104-4470

Device Problem Burst Container or Vessel (1074)

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

Event Date 12/21/2017

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for evaluation yet; however, it is on the way back.Once the device is received and evaluated, a supplemental report will be sent out.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that the hyperform occlusion balloon ruptured during preparation.It was noted that 0.06cc of 50/50 (contrast/saline) was injected into the balloon when it ruptured.No patient injury was reported as the event occurred outside the patient.

Manufacturer Narrative

The event occurred during preparation of a procedure for treatment.The hyperform balloon catheter and guidewire were returned for analysis.Based on the device analysis and reported information, the customer¿s report of ¿rupture¿ was confirmed.Although the balloon was found to be not ruptured, the catheter body was found to be ruptured.Foreign material found within the balloon catheter lumen was analyzed using ftir (fourier transform infrared spectroscopy) and found to be a fibrous bundle primarily composed of cellulosic flat, white fibers and clear, round pet (polyethylene terephthalate) fibers.Potential fibers found in the manufacturing floor were sent out for ftir testing.The ftir spectrums were reviewed, none of the ftir spectrums matched the foreign material found within the balloon catheter lumen.Therefore, it is likely this foreign material originated from surgical gauze/clot used during the event.Particulate from surgical gauze/cloth can adhere to the surface of a guidewire subsequently depositing within the balloon catheter lumen during guidewire insertion, occluding the catheter, and causing the catheter shaft to inflate and rupture at a location more proximal than the balloon.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.All products are 100% inspected for damages and irregularities during manufacture.As noted in the hydrophilic guidewire ifu (instructions for use): ¿between uses, place the guidewire in a basin of saline, or fill the packaging coil with saline and replace the guidewire between uses.Avoid wiping down with damp cloths, particulate from the cloth can adhere to the surface of the guidewire.¿ if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Manufacture city to (b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The hyperform balloon catheter and guidewire were returned for analysis and were decontaminated.Upon visual inspection, no issues were found with the balloon catheter hub.The balloon catheter body was found to be ruptured at approximately 1.5cm from the distal tip.Upon visual inspection no damages or irregularities were found with the balloon.An unsuccessful attempt was made to flush the balloon catheter.The balloon catheter was then tested with an in-house x-pedion-10 guidewire.The in-house guidewire was hydrated and inserted into the balloon catheter hub.The in-house guidewire was unable to pass through the distal tip as it became stuck between the proximal and distal marker bands.Upon examination, what appears to be a foreign material was found within the balloon catheter lumen between the proximal and distal marker bands.The foreign material was pushed out from within the lumen and sent out to s n labs for material identification testing.The occlusion balloon catheter was flushed, water exited from the rupture site and distal tip.The returned guidewire was examined.The guidewire distal tip was found to be bent.Visual inspection of the remainder of the guidewire, apart from the bent tip, revealed no other damage or irregularities.The od (outer diameter) of the guidewire was measured, with the digital snap gauge, at three locations and found to be within specification.No other anomalies were observed.An additional supplemental report will be sent out once we receive the information back from s&n labs.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HYPERFORM
• Type of Device: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 7212681
• MDR Text Key: 98020982
• Report Number: 2029214-2018-00054
• Device Sequence Number: 1
• Product Code: MJN
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K011656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/02/2018

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: 08/30/2019
• Device Model Number: 104-4470
• Device Lot Number: A425945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2017
• Initial Date FDA Received: 01/23/2018
• Supplement Dates Manufacturer Received: 12/26/2017; 02/22/2018; 07/25/2018
• Supplement Dates FDA Received: 01/23/2018; 02/23/2018; 08/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2017
• 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