MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS QUICKCAT EXTRACTION CATHETER; CATHETER, EMBOLECTOMY

Model Number	60090-01
Medical Device Problem Code	Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information unavailable, although multiple requests have been made initial reported information unavailable, although multiple requests have been made the manufacturer has no information that this device will be returned.However, due to the limited amount of information obtained by the manufacturer, additional information is still being sought and the investigation into this complaint continues.
Event or Problem Description
The manufacturer received a complaint from (b)(6) that during use in a procedure (patient details and details surrounding the procedure have not been obtained, but multiple requests have been made), a spectranetics quickcat extraction kit was noted to not contain, within the packaged device, the necessary "stop or start" for the syringe stem to maintain negative pressure of the aspirator.When again asked what portion of the device was missing, the philips representative stated that the syringe was missing.Due to limited detail, it is unknown how the patient was treated; however, the information did state there was no patient injury.This report is being submitted due to the potential for serious injury with recurrence.
Additional Manufacturer Narrative
Section a): no patient information available.Additional procedure detail provided.The procedure was reported to treat a plaque lesion in the mid circumflex vessel.It was reported that the aspiration syringe did not have the necessary ''stop device'' for the syringe stem to maintain the negative pressure of the aspirator.It was reported this was not a product failure; the product was reported incomplete inside the sterile packaging.The procedure was reportedly completed with another device.H3): the manufacturer was informed on (b)(6) 2021 that the quickcat device had been discarded and is not available for evaluation.H6): method, results and conclusions codes now populated, capturing the device was discarded and not available for evaluation.Conclusions code 4315, "cause not established", was used.Checks (to ensure that all device components are present) are performed in two different process steps during the manufacturing process and the device passed all qc checks prior to release for distribution.It cannot be determined when or how the reported device component went missing.Section e): physician name provided.

• Brand Name: SPECTRANETICS QUICKCAT EXTRACTION CATHETER
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 11289838
• Report Number: 1721279-2021-00019
• Device Sequence Number: 3283206
• Product Code: DXE
• UDI-Device Identifier: 00813132020989
• UDI-Public: (01)00813132020989(17)230601(10)FQT20E29A
• Combination Product (Y/N): Y
• Initial Reporter Country: CI
• PMA/510(K) Number: K073519
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2021

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: 06/01/2023
• Device Model Number: 60090-01
• Device Catalogue Number: 60090-01
• Device Lot Number: FQT20E29A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO CONCOMITANT DEVICES REPORTED
• Outcome Attributed to Adverse Event: Other