MAUDE Adverse Event Report: IMPERATIVE CARE. INC ZOOM REPERFUSION CATHETER; CATHETER, THROMBUS RETRIEVER

Model Number ICRC035158

Device Problems Break (1069); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/11/2022

Event Type  malfunction  

Manufacturer Narrative

Zoom 35 catheter was returned for investigation.The inspection of the complaint device confirmed that a 9.6cm portion of the distal end of the zoom 35 was protruding from the distal tip of the zoom 55.An attempt was made to remove the zoom 35 from the zoom 55 but was unsuccessful due to an interference condition between the two devices.The break location was noted to be at one of the catheter junctions.There was a small section of stretched inner liner visible on the remainder of the proximal end of the zoom 35.In addition, a torn outer jacket and exposed metal were noted.A stretched section of the zoom 55 was found at the strain relief of the luer that appeared to have been twisted.The tip opening of the zoom 55 was observed to be slightly ovalized.Based on the information provided, the physician felt resistance when retracting zoom 35.Per zoom 35 instructions for use: "do not advance or withdraw the zoom catheter or accessory/adjunctive devices against resistance without careful assessment of cause under fluoroscopy.If the cause cannot be determined, withdraw all devices as a single unit.Excessive manipulation and torquing the device against resistance may result in damage to the vasculature or the device" and "do not use kinked devices." the manufacturing records of this lot were reviewed and did not reveal any issues pertaining to design, manufacturing, or quality.

Event Description

The patient was being treated for an occlusion at the right middle cerebral artery (mca) m2 segment.Zoom 35 and zoom 55 were removed from packaging and flushed.A guidewire was flushed and loaded into zoom 35.Zoom 35 was inserted into zoom 55, and the assembly was placed in heparinized saline.Access was successfully gained with zoom 88.While access was being obtained, zoom 35 and zoom 55 assembly was moved to the sterile field for a short period of time.When inserting the zoom 35 and zoom 55, the physician noted the assembly felt "sticky".The assembly was advanced through the vasculature to the clot.When the physician tried to retract zoom 35 into zoom 55, he felt resistance.Additional effort was made to pull the zoom 35.The catheter fractured and proximal portion of the zoom 35 was removed.The distal end of the zoom 35 was in the zoom 55 and both catheters were removed as one unit.There was no intervention required as there was no foreign material left in the body.The physician continued the case with a new assembly of zoom 71 and zoom 35.The case was successfully completed with one pass.The patient achieved tici 3 result and nihss score went from 17 pre-procedure to 1 the following day.

• Brand Name: ZOOM REPERFUSION CATHETER
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): IMPERATIVE CARE. INC; 1359 dell avenue; campbell CA 95008 6609
• Manufacturer (Section G): IMPERATIVE CARE, INC; 1359 dell avenue; campbell CA 95008 6609
• Manufacturer Contact: joy patel ; 1359 dell avenue; campbell, CA 95008-6609
• MDR Report Key: 14053393
• MDR Text Key: 292055358
• Report Number: 3014590708-2022-00007
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00812212030443
• UDI-Public: 00812212030443
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2023
• Device Model Number: ICRC035158
• Device Catalogue Number: ICRC035158
• Device Lot Number: F2200302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2022
• 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
• Treatment: ARISTOTLE 18 GUIDEWIRE.; ZOOM 55.; ZOOM 71.; ZOOM 88.