MAUDE Adverse Event Report: CONCENTRIC MEDICAL DAC 070 105CM; CATHETER, PERCUTANEOUS

Catalog Number	90770
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
It was reported that during innominate artery stenosis (ias) occlusion case, the distal of the subject device was found to be broken after reaching the place and did aspiration.So the operator replaced it with other catheter to finish the procedure.There were no reported clinical consequences to the patient due to this event.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.There was no break observed during visual inspection.The dac was compressed in several places along its proximal shaft and severely compressed (flattened) on its distal shaft.Additionally, the distal tip marker was also compressed; likely due to some procedural factors encountered during use.It is possible that the dac was damaged when it was withdrawn from the treatment site following aspiration.However, the exact cause could not be definitively determined as no resistance was reported during the procedure and the patient's anatomy was not reported to be tortuous.From the condition of the device, the functional test could not be performed.The device was stated to have been in a good condition prior to the procedure and was prepared as per device directions for use (dfu).Additional information provided by the customer indicated that there was no allegation against the catheter that was used with the dac.No other items were returned with the dac for analysis.Based on results of the investigation and available information, the reported shaft broken was not confirmed.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that during innominate artery stenosis (ias) occlusion case, the distal of the subject device was found to be broken after reaching the place and did aspiration.So the operator replaced it with other catheter to finish the procedure.There were no reported clinical consequences to the patient due to this event.

• Brand Name: DAC 070 105CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): CONCENTRIC MEDICAL; 301 east evelyn; mountain view CA 94041
• MDR Report Key: 8177548
• Report Number: 0002954917-2018-00083
• Device Sequence Number: 13717629
• Product Code: DQY
• UDI-Device Identifier: 07613327313932
• UDI-Public: 07613327313932
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K151667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2019
• Device Catalogue Number: 90770
• Device Lot Number: 63181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 01/28/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 72