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 08/24/2022

Event Type  Injury  

Event Description

The patient was undergoing a thrombectomy procedure to treat an occlusion at the inferior right m2 segment.The patient had a mild tortuous anatomy with a steep turn into the inferior division of m2.The patient also had very calcified vessels.The clot was not removed after first pass with zoom 71.The physician introduced a stent retriever and a competitor's microcatheter which was tracked through zoom 71 to the location of the clot.The microcatheter was removed and the stent retriever was deployed to the clot.While trying to remove the stent retriever and zoom 71 at the same time, the physician felt and heard the zoom 71 fracture.The broken zoom 71 was retrieved with a snare.The patient was reported to be stable and no patient sequelae was reported.

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.Investigation demonstrated stretching, buckling, and kinking of the catheter.Based on the information obtained, no case images provided, and return of the zoom71 catheter only 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: 15470382
• MDR Text Key: 300441067
• Report Number: 3014590708-2022-00017
• 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: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2023
• Device Model Number: ICRC071137
• Device Catalogue Number: ICRC071137
• Device Lot Number: F2216701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2022
• 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: EMBOTRAP STENTRIEVER; MARKSMAN CATHETER; SYNCHRO GUIDEWIRE; ZOOM 88
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female