MAUDE Adverse Event Report: TERUMO CLINICAL SUPPLY CO., LTD. PRIORITYONE; ASPIRATION CATHETER

Model Number	UG1602
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported the aspiration catheter, priority one, was used for a thrombectomy.Multiple attempts were successful (5-6 times).There was more clot distally, so they advanced the catheter but stuck.When pulling it, the catheter's tip dislodged in the left main.An attempt to extract the fragment was made without success, then it migrated to the thorax.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: age or date of birth: requested, not provided.A3b: gender: n/a.A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.Terumo medical products (tmp)(importer) registration no.(b)(4) is submitting this report on behalf of terumo clinical supply co., ltd.(manufacturer) registration no.3009500972.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to provide the completed investigation results.The actual device was not returned; therefore, we performed out the following investigation.Using the eliminate device (family of priority one ac) and a ptca trainer, we attempted to reproduce the distal marker separation observed in the involved device.We set a guidewire of the appropriate size on the eliminate sample and inserted a guiding catheter of the appropriate size into the ptca trainer.We then performed guidewire operations and formed a loop on the combination guidewire.In this state, we operated the eliminate sample.When a loop was formed on the guidewire, it continued to be pulled against resistance.The guidewire lumen began to tear from the proximal port and continued to tear along its entire length, resulting in the distal radiopaque marker of the eliminate device being torn off.Result: the simulation test showed the same reproducibility of damage as observed in the device involved.In our company, we conduct visual inspections on all priority one ac devices.After reviewing the device history records for lot 230700660, we found no abnormalities that could cause the separation of the distal marker.We investigated the complaint records for production lot 230700660 of the device in question and found no similar complaints reported in the past.Based on past experiences, it is known that our priority one ac may cause the gw lumen to tear and the tip marker to come off when the removal operation is performed while the combination gw is stuck.It was considered that the separation of distal part that occurred in the involved device may have occurred by the same mechanism: 1) the aspiration catheter is being pulled, leaving the guide-catheter and guidewire in place.2) a loop is being formed on guidewire, and operator may feel resistance against withdrawal.3) the looped guidewire makes gw-lumen tube become torn, and aspiration catheter and guidewire are stuck in guide-catheter.However, since the device involved was not returned and the damage status could not be confirmed, the cause of the separation of the distal part in the device could not be identified in this investigation.

• Brand Name: PRIORITYONE
• Common Device Name: ASPIRATION CATHETER
• Manufacturer (Section D): TERUMO CLINICAL SUPPLY CO., LTD.; 3 kawashima-takehayamachi; kakamigahara; gifu, 501-6 024; JA 501-6024
• Manufacturer (Section G): TERUMO CLINICAL SUPPLY CO., LTD.; reg. no. 3009500972; 3 kawashima-takehaya-machi; kakamigahara, gifu, 501-6 024; JA 501-6024
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 19786017
• Report Number: 3009500972-2024-00005
• Device Sequence Number: 8269308
• Product Code: QEZ
• UDI-Device Identifier: 04543334177254
• UDI-Public: 04543334177254
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: UG1602
• Device Catalogue Number: 30-6100
• Device Lot Number: 230700660
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 07/19/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female