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 08/22/2022

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure to treat a tandem occlusion at internal carotid artery (ica) and m1/m2 segments.Access was obtained with a guidewire, competitor catheter and zoom 88.After the first pass recanalization was unsuccessful.The guidewire and competitor catheter were removed, and the physician made the next pass with another competitor microcatheter, zoom 71 and the same zoom 88.There was some resistance encountered during advancement of the microcatheter and zoom 71 to the face of the clot.M1 and m2 segments were partially recanalized.Zoom 71 was removed and no damage to the catheter was observed.With zoom 88 in track, the physician advanced the guidewire, competitor microcatheter and the same zoom 71 to the face of the clot.Only the guidewire penetrated the clot.Zoom 88 was then advanced over zoom71 to the m1 segment.Some resistance was encountered while traversing past the ophthalmic.The physician started aspiration with zoom 71 and zoom 88 using two pumps.Upon removal of the catheters, approximately 3-4 centimeters of the distal shaft of zoom 71 was broken and the microcatheter was observed to be twisted.A follow-up computed tomography (ct) scan showed no foreign material was left in the patient.The aspirated clot showed heavy calcification.There was no harm to the patient reported.The patient achieved tici 3 score.

Manufacturer Narrative

Only the zoom 71 catheter was returned for investigation.Upon investigation it was determined that there was shaft breakage at the distal end of the catheter.Investigation demonstrated stretching of the catheter.Based on the information provided and only return of the zoom71 catheter the exact root cause of shaft breakage could not be determined.The manufacturing records were reviewed, and demonstrated the product met all the design and manufacturing specifications.

• 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: 15457447
• MDR Text Key: 306428094
• Report Number: 3014590708-2022-00016
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00812212030450
• UDI-Public: 00812212030450
• 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: Physician
• Type of Report: Initial
• Report Date: 09/20/2022

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: 06/22/2023
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2216601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2022
• Initial Date FDA Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2022
• 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: PHENOM MICROCATHETER; SYNCHOR GUIDEWIRE; ZOOM 88
• Patient Age: 69 YR
• Patient Sex: Female