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

Model Number ICRC071137

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

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

Event Date 12/10/2021

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure to treat an acute ischemic stroke secondary to an automobile accident.The patient was also being treated for intracranial atherosclerotic disease (icad) in the target vessel for thrombectomy (m1).A total of three passes were made.After the first pass, the physician felt resistance while retracting zoom 71 through the ici rotating hemostasis valve (rhv).The entire zoom 71 was removed and upon observation on the operating table, it was noticed the catheter shaft had fractured.There was no resistance felt during advancement of this catheter.The physician commented the catheter was caught on the rhv which was possibly not fully opened when retracting.The device was replaced with another zoom 71 and second pass was performed without any issues.Second zoom 71 was removed, and the physician made the third pass using zoom 55.The case was completed with successful reperfusion of m1 segment.In addition, the patient was treated for intracranial atherosclerotic disease (icad) with angioplasty and stent.The patient was reported as stable.There were no patient sequalae reported.

Manufacturer Narrative

Zoom 71 catheter was returned for investigation.The returned device includes two segments of the zoom 71.There were no additional adjunctive devices returned.The combined length of the catheter measured shorter than the required specification.The review of the images provided by the customer indicates that stretched portions between the returned distal and proximal segment were not returned.The proximal end of the distal segment is stretched, with no protruding coils or materials.The proximal segment is also stretched on the distal end with protruding and elongated coil material.Four kinks are present along the proximal segment, and the catheter is flattened from the distal end of the proximal strain relief.The root cause of the shaft separation was determined to be retraction of catheter against resistance, specifically due to the overtightened rhv.Per zoom 71 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.Appropriate testing and inspection were completed to ensure the device met minimum tensile specification and is kink resistant.The distal section undergoes 100% visual inspection and is free of visual defects or protrusions.The overall length of the device is also verified 100%.

• 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: 13198027
• MDR Text Key: 292054607
• Report Number: 3014590708-2022-00001
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00812212030191
• UDI-Public: 00812212030191
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2022
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2129501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2021
• 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: INTRACRANIAL STENT.; ZOOM 55.
• Patient Sex: Male