MAUDE Adverse Event Report: CONCENTRIC MEDICAL V 2.5 SOFT EXT; CATHETER, THROMBUS RETRIEVER

Catalog Number 90111

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Vasoconstriction (2126)

Event Date 05/06/2012

Event Type  Injury  

Manufacturer Narrative

The subject device was disposed of at the hospital.

Event Description

It was reported that vasospasm occurred after a mechanical thrombectomy was performed with the subject retriever for cardiogenic occlusion at the basilar artery; therefore, percutaneous transluminal angioplasty (pta) was performed.The physician restored patency to the vessel; however, the vessel was reported to be re-blocked and was in the same perfused state as prior to procedure (thrombolysis in cerebral infarction score 0).No further information is available.

Manufacturer Narrative

The device history record review was unable to be performed as the reported lot number (1020) of the device does not match any of the manufacturer's lot numbers for this device.The subject device is not available; therefore analysis cannot be performed.From the information available, there is no indication that the reported event is related to product specifications nonconformance or misuse.There is also no indication that the subject device malfunctioned.However, vessel spasm is a known risk associated with such procedures and noted as such in the directions for use (dfu).Therefore, a root cause of anticipated procedural complication has been assigned to the event.

Event Description

It was reported that vasospasm occurred after a mechanical thrombectomy was performed with the subject retriever for cardiogenic occlusion at the basilar artery; therefore, percutaneous transluminal angioplasty (pta) was performed.The physician restored patency to the vessel; however, the vessel was reported to be re-blocked and was in the same perfused state as prior to procedure (thrombolysis in cerebral infarction score 0).No further information is available.

• Brand Name: V 2.5 SOFT EXT
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): CONCENTRIC MEDICAL; 301 east evelyn; mountain view CA 94041
• Manufacturer (Section G): CONCENTRIC MEDICAL; 301 east evelyn; mountain view CA 94041
• Manufacturer Contact: sanda dracic ; 301 east evelyn; mountain view, CA 94041 ; 6509382100
• MDR Report Key: 5336353
• MDR Text Key: 34736124
• Report Number: 0002954917-2015-00163
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• PMA/PMN Number: K090085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 90111
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 80 YR