MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION 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  

Manufacturer Narrative

A5: ethnicity: not provided for animal use.A6: race: not provided for animal use.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.As no actual sample was available, the following investigation was performed.The manufacturing record and the shipping inspection record of the product with the involved product code/lot number found no anomaly.No other similar report from other facilities was found.Based on the investigation result, no anomaly was found in the manufacturing record and the shipping inspection record of the actual product.As a possible cause of this case, the following mechanism was inferred.However, since the actual sample could not be confirmed, it was not possible to clarify the cause of occurrence.The actual product was elongated due to some factors.Since the actual product was elongated and the lumen was narrow, when an attempt was made to pull a combined coil into the actual product, it could not be pulled in.An attempt was made to pull in the coil further, as a result, the coil separated.In addition, the actual product was torn.Ashitaka factory is always continuing diligence in maintaining the product quality by performing following inspections and work.The product is always flowed in the production process with a core wire inserted in the lumen so that the catheter lumen is assured.In the product assembling process, the outer diameter is inspected on 100% basis to confirm that there is no anomaly in the outer diameter of catheter.Before the packaging process, 100% visual inspection is performed to confirm that there is no anomaly such as a kink or an elongation.Please pay attention to the following warnings included in the instructions for use (ifu) for future use: "[directions for use 8.Warnings] if any resistance is felt in the vessel, do not advance or withdraw the catheter until the cause of resistance is determined through a high-resolution fluoroscope and a digital subtraction angiography monitor.Manipulating the catheter and/or the guide wire against resistance may result in damaging the vessel, the catheter or the guide wire." terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

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 MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 4103927218
• MDR Report Key: 18838156
• MDR Text Key: 336909185
• Report Number: 9681834-2024-00031
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 04987350718440
• UDI-Public: 04987350718440
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033913
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• 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
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 018 AZUR HYDROPACK; 018 THROUGHWAY WIRE; 035 AQUATRACK WIRE; 035 RUBICON SUPPORT CATHETER; 10 CM COIL; 6 FR DESTINATION 90 CM SHEATH
• Patient Outcome(s): Other