MAUDE Adverse Event Report: VOLCANO ATHEROMED, INC. QUICKCLEAR 8F; CATHETER, EMBOLECTOMY

Model Number	AC8SH085
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient info: no information available.This information was not available from the facility.Relevant tests/laboratory data/other relevant history: no information available.This information was not available from the facility.The quickclear device was discarded by the facility, thus no returned product investigation was performed.Per the ifu, fracture malfunction of any component of the device that may or may not lead to serious injury or surgical intervention is listed as a possible adverse event.
Event or Problem Description
It was reported that during a peripheral procedure, the tip of the quickclear partially separated while inside the patient, but did not fully detach into two pieces.The device was able to be removed alone and the wire and sheath remained.There was no resistance noted during delivery or retraction.A new quickclear device was used to complete the procedure.No patient injury reported.This product problem is being submitted because the tip of the quickclear device partially separated.There is a potential for harm if the malfunction were to recur.
Additional Manufacturer Narrative
Blocks d1/ g1: manufacturer name and address was updated from spectranetics, 6655 wedgwood road north, suite 105, maple grove mn, 55311 to volcano atheromed, inc., 1530 o brien drive, suite a, menlo park ca, 94025 to match the information on the product label.
Additional Manufacturer Narrative
Blocks d1/ g1: manufacturer address was updated from (b)(6).This correction was made to align the address with the fda registration number.

• Brand Name: QUICKCLEAR 8F
• Common Device Name: CATHETER, EMBOLECTOMY
• Manufacturer (Section D): VOLCANO ATHEROMED, INC.; 6655 wedgwood road north; suite 105; maple grove MN 94025
• Manufacturer (Section G): VOLCANO ATHEROMED, INC.; 6655 wedgwood road north; suite 105; maple grove MN 94025
• Manufacturer Contact: ana tan ; 6655 wedgwood road north; suite 105; maple grove, MN 55311
• MDR Report Key: 12584724
• Report Number: 3011416935-2021-00033
• Device Sequence Number: 3632345
• Product Code: DXE
• UDI-Device Identifier: 00845225003128
• UDI-Public: 00845225003128
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K193197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/03/2023

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: 05/31/2022
• Device Model Number: AC8SH085
• Device Catalogue Number: AC8SH085
• Device Lot Number: 301935524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 09/21/2021; 09/21/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 05/19/2023; 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO: 0.035" GLIDEWIRE ADVANTAGE GUIDEWIRE; TERUMO: 8F PINNACLE INTRODUCER SHEATH
• Patient Sex: Unknown