MAUDE Adverse Event Report: Q'APEL MEDICAL INC. 072 ASPIRATION SYSTEM; CATHETER, THROMBUS RETRIEVER

Model Number	FG 00806-02
Medical Device Problem Codes	Use of Device Problem (1670); Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Aspiration system (hippo) was being removed/backed out of the zoom rdl following aspiration.Dr (b)(6) attempted to pass a zoom 71 through the zoom rdl on a second pass and it would not advance through.The zoom rdl and zoom 71 were then completely removed from the body in which it was discovered that there was a piece of the hippo inside the rdl towards the distal tip.No part of the hippo tip remained in the patient.
Additional Manufacturer Narrative
The returned catheter was measured from the hub using a ruler and measured ~135cm which is longer than the catheter mfg.Length (~132cm).The tip was visibly missing from the catheter with an unwound coil protruding from the distal end.The device was observed to have significant flattening of the catheter and elongation starting at ~20 cm from the distal end, however, there was no visible impact to the catheter coil spacing.Using a microscope, no visible liner was present, which denotes that the failure was within the ts 1 section or distal tip.Based on the reported complaint event intake that the detached hippo segment remained within the zoom rdl catheter, the compatibility between the devices had remained for some portion at the distal end of the rdl catheter when removal of the device had commenced.The physical evidence of the returned hippo catheter, with visual deformations, is consistent with the hippo catheter becoming stuck due to a kink in the rdl catheter that prevented the hippo catheter distal tip from passing through that kinked point.Lbs 00807 072 aspiration system ifu rev.D was reviewed.In the warning section: never advance or withdraw an intravascular device against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the device against resistance could dislodge a clot, perforate a vessel wall, or damage the device.Torqueing the catheter excessively while kinked may damage the device, resulting in separation of the catheter shaft.Withdraw the entire device (the device, microcatheter, and guidewire) if the device is severely kinked.

• Brand Name: 072 ASPIRATION SYSTEM
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): Q'APEL MEDICAL INC.; 4245 technology drive; fremont 94538
• Manufacturer (Section G): Q'APEL MEDICAL INC.; 4245 technology drive; fremont
• Manufacturer Contact: michael wilcox ; 4245 technology drive; fremont 94538
• MDR Report Key: 19583959
• Report Number: 3015614180-2024-00007
• Device Sequence Number: 7392736
• Product Code: NRY
• UDI-Device Identifier: 00857545008097
• UDI-Public: 00857545008097
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K222786
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/19/2024

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: 09/07/2024
• Device Model Number: FG 00806-02
• Device Catalogue Number: AP6072-132
• Device Lot Number: FG240308A-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2024
• Initial Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2024
• 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
• Patient Sex: Unknown