MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA PROGREAT CATHETER; CATHETER, CONTINUOUS FLUSH

Model Number N/A

Device Problems Stretched (1601); Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 02/12/2024

Event Type  Injury  

Event Description

The user facility reported that a 6 french 90cm destination sheath was placed into the left brachial artery and extended into the distal aorta.An 035 rubicon catheter was placed into a small branch off the right internal iliac artery and a 018 thruway wire was placed.The 2.4 french progreat was placed over the wire with great resistance felt by the technologist loading it.It was noted by the physician that the technologist was accidentally pinning the catheter tip and pushing the back end of the catheter.After the technologist repositioned their hands, the catheter was able to be delivered to the appropriate location over the wire.The wire was removed, and the 018 10cm hydopack coil was introduced.One coil was successfully delivered.The second coil was delivered; however, intended to be repositioned and upon removal, the coil became detached due to resistance and the tail of the coil was hanging into the common iliac artery in an unwanted location.The progreat was removed; however, it was elongated and partially torn.The physician decided that no additional intervention was necessary at this time.The procedure performed was a type 2 endoleak embolization of right internal iliac branch.The patient had a prior 10cm aaa with prior endovascular surgery.The estimated blood loss was less than 250cc's.The coil was unable to be pulled back into the catheter and caused poor coil positioning.There was no direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.

• Brand Name: PROGREAT CATHETER
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 18838280
• MDR Text Key: 336910833
• Report Number: 2243441-2024-00003
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 04987350718440
• UDI-Public: 04987350718440
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2024

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MC*PV2415Y
• Device Lot Number: 221202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/05/2024
• Distributor Facility Aware Date: 02/12/2024
• Device Age: 14 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 018 AZUR HYDOPACK; 018 THROUGHWAY WIRE; 035 AQUATRACK WIRE; 035 RUBICON SUPPORT CATHETER; 10 CM COIL; 6 FR DESTINATION 90 CM SHEATH
• Patient Outcome(s): Other