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

Model Number 60090-01

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/11/2021

Event Type  malfunction  

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 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.

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
• Type of Device: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 11289838
• MDR Text Key: 255121302
• Report Number: 1721279-2021-00019
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00813132020989
• UDI-Public: (01)00813132020989(17)230601(10)FQT20E29A
• Combination Product (y/n): Y
• PMA/PMN Number: K073519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO CONCOMITANT DEVICES REPORTED
• Patient Outcome(s): Other