MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA TERUMO PROGREAT CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/25/2022

Event Type  malfunction  

Manufacturer Narrative

Date of birth: requested, not provided.Ethnicity: requested, not provided.Race: requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.Establishment name: (b)(6) college.From the provided photo, it was found that the actual catheter was cut off in two places.No fracture was found on the distal end.Review of the manufacturing record and the shipping inspection record of the involved product code/lot number combination confirmed that there were not any indications of anomaly in them.A search of the complaint file found no other similar report for the involved product code/lot number combination from other facilities.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that the distal end of the progreat device broke during imaging (pressure value when inserted the contrast agent: 450psi).The operator was able to successfully grab the broken piece with a catcher.There was no patient injury/medical or surgical intervention required.The final patient impact was not harmed.The event occurred intra-operative.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide additional infomration to secton b5, the device return date in section d9, update section h3, and to provide the completed investigation results.From the provided photo, it was found that the actual catheter was cut off in two places, and there was a cut piece.No missing part was found in the distal section.The returned sample had only its distal side, and no cut piece.Its hand side was returned.Visual inspection of the actual sample found that it had been cut off at approximately 910mm from the distal end.No missing part was found in the distal section.Magnifying inspection of the cut section found that the stainless-steel reinforcement had been exposed, and the cut section had been crushed into an oval shape.The outer and inner diameters of the actual sample (normal sections) were measured and confirmed to meet the specifications.The following simulation test was performed in the past.A factory-retained progreat was inserted into a factory-retained angiographic catheter (glidecath, with a stopcock).The operation of closing the stopcock by approximately 90 ° was performed.After operating the stopcock, the progreat was removed from the angiographic catheter and visual inspection of it was performed.It was found that the catheter was cut off in two places at the stopcock operating section, and there was a cut piece.This was very similar to the condition in the provided photo.The length of the cut piece was approximately 6mm.Magnifying inspection of the cutting section found that the stainless-steel reinforcement was exposed, and the cutting section was crushed in an oval shape.It was very similar to the condition of actual sample.Based on the investigation result, as a possible cause of this complaint, it was likely that since the stopcock was operated with the actual sample inserted in the device used in combination (e.G., angiographic catheter with a stopcock), the actual sample was caught in the stopcock and was cut off.Relevant ifu reference: "if the guiding catheter is fitted with a stopcock, do not close the stopcock with the catheter inside the guiding catheter.The catheter may be broken.".

Event Description

Additional information was received on 24 aug 2022: the hand side was confirmed to be missing for an unknown reason.

• Brand Name: TERUMO PROGREAT CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 6402040886
• MDR Report Key: 15266505
• MDR Text Key: 298984611
• Report Number: 9681834-2022-00177
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K033583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: MC-PC2413
• Device Lot Number: 220404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2022
• 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
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 60 KG