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

Model Number ICRC055137

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

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

Event Date 01/18/2024

Event Type  malfunction  

Event Description

Initial access was obtained radially with a zoom rdl.The treating physician attempted to insert a zoom 55 but was unsuccessful.The physician believed there was a kink, possibly at the distal third on the zoom rdl.The patient's anatomy was not tortuous, and there was no abnormal interaction or resistance between the catheters prior to noticing the kink.Both the zoom rdl and the zoom 55 were removed from the patient.After removal, the physician reported noticing a kink on both zoom 55 and zoom rdl and believes the kink on the zoom rdl caused the zoom 55 to kink.The location of the kink on the zoom 55 is unknown.The physician aborted the radial approach and proceeded with a femoral approach.Femoral access was obtained with a zoom 88 catheter.After inserting a new zoom 55 into the patient, the treating physician reported that the zoom 55 radiopaque (ro) marker was not visible under fluoroscopy.The physician removed the zoom 55 from the patient, examined it under fluoroscopy, and reported that the ro marker was not visible on the zoom 55.No ro marker was found inside the patient.It is unclear whether there was any resistance during introduction or removal of the zoom 55.No kink was observed on the zoom 88.A third zoom 55 was used to complete the procedure.The patient was reported to be stable without any sequelae.On 01/29/2024, the reported zoom rdl and the first zoom 55 used during radial approach procedure were returned and examined.The kink on the rdl was confirmed.However, the zoom 55 was received with a broken shaft.Several attempts were made to verify when the zoom 55 shaft broke, but without success.

Manufacturer Narrative

Only the zoom rdl and zoom 55 used during the radial approach procedure were returned for investigation.The zoom 55 with the reported ro marker missing was not returned for investigation.The manufacturing records for all devices were reviewed and demonstrated that the products met all the design and manufacturing specifications.Zoom 55 with broken shaft: a distal segment of the zoom 55 used during the radial approach was returned and was contained within the distal end of a zoom rdl device.The proximal end of the zoom 55 was returned separate from the zoom 55 distal segment and zoom rdl device.The shaft breakage on the zoom 55 indicates that an axial force was applied at an unknown time resulting in stretching the shaft materials prior to the device breaking.The distal segment of the zoom 55 extended out of the zoom rdl tip and was held inside the zoom rdl catheter shaft by a kink on the zoom rdl.The zoom 55 distal segment had kinks present and catheter jacket materials were observed stretched at the break location.The corresponding proximal segment was observed to have minimal stretching of materials at the break.Based on device investigation and additional follow-up attempts, the cause for the shaft breakage on the zoom 55 could not be determined.Per the follow-up information received, shaft breakage was not noted.Additionally, it was determined that all zoom catheters used during the case were initially discarded and were later the zoom rdl and first zoom 55 were retrieved from disposal for return to imperative care for investigation.It is unknown if the break occurred during use or post procedure.Zoom 55 with missing ro marker: based on the information provided for the zoom 55 device reported to have a missing ro marker and without the device being returned, confirmation and root cause for the missing ro marker could not be determined.Additional follow-up attempts were made to confirm the missing ro marker.It was also reported that the tip of the zoom 55 with the reported missing ro marker had the angled tip.Investigation of the manufacturing process was completed.Based on how the ro marker is attached to the device and how the angled tip is manufactured the possibility of manufacturing a zoom 55 without the ro marker or the ro marker coming off the device is remote.There are multiple points during the manufacture of each zoom 55 that require verification of the presence of the ro marker.In addition, the angle of the device tip is created based on the location of the ro marker and the ro marker is embedded between layers of materials on the distal end of the catheter.The following mfr # were submitted: mfr # this report for zoom 55 (1 of 2) with broken shaft.Mfr # 3013590708-2024-00004 for zoom 55 (2 of 2) with the missing ro marker.

• 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; campbell, CA 95008-6609
• MDR Report Key: 18727436
• MDR Text Key: 335826500
• Report Number: 3014590708-2024-00011
• Device Sequence Number: 1
• Product Code: NRY
• 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: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ICRC055137
• Device Catalogue Number: ICRC055137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: ZOOM 88.; ZOOM RDL.
• Patient Age: 30 YR
• Patient Sex: Male