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

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/22/2022

Event Type  Injury  

Event Description

The user facility reported that during embolization of a type ii endoleak and during attempting several wire and catheter combinations to navigate through the arterial arcade and gain access to the interior mesenteric artery, a terumo progreat 2.4fr microcatheter with a fathom wire was used to attempt crossing a tight stenosis at a hairpin turn.The attempt was unsuccessful to allow for safe embolization.Upon removing the progreat microcatheter after being unable to cross the lesion, it was noted on fluoroscopy that a radiopaque 0.7mm platinum/iridium marker that was previously at the end of the catheter had become dislodged into the stenosis.After removal of the microcatheter and wire from the veteran, the provider confirmed the tip of the catheter and wire were intact, however, noted the outside radiopaque marker had become dislodged.Using the same wire and catheter, we selected the superior mesenteric artery (sma) and confirmed correct placement with angiography.We then advanced our sheath into the superior mesenteric artery (sma) with the dilator and repeated the angiogram to mark the arc of riolan and the meandering artery branch off the superior mesenteric artery (sma) feeding into and collateralizing with the ima.We had difficulty traversing given the tortuosity and intermittent stenoses of this branch.We used a combination of glide wire and glide catheter, 0.018 glide advantage wire and glide catheter and quick cross catheter, fathom wire with nested glide catheter and 0.018 cxi catheter as well as jr-4 catheter nested with a terumo progreat 2.8 microcatheter and a 0.018 glide advantage wire.Of note, the jr-4 catheter provided us the best support and angle for selection of the leftward-going early superior mesenteric artery (sma) branch to the arc of riolan and the 0.018 glide advantage wire the best push ability and navigation around the tortuosity.Nevertheless, there was severe spasm of the marginal artery branch, refractory to intra-arterial injection of 200mcg of nitroglycerin.On our last attempt, we found the 0.018 the wire to be extraluminal as it attempted to navigate around a tight turn.The catheters and wires were slowly pulled back and repeat angiogram confirmed intraluminal placement with no evidence of extravasation.We however noted that radiopaque tip of the progreat catheter had at some point become dislodged into an area that was difficult to traverse.The estimated blood loss was less than 250cc.The patient was in stable condition.Procedure outcome: impression: - type ii endoleak from inferior mesenteric artery (ima).Unable to traverse the arc of riolan via superior mesenteric artery (sma) collaterals into the inferior mesenteric artery (ima) due to tortuosity and stenoses.Distal radiopaque platinum/iridium mar.Additional information was received on 19 jan 2023: there was no medical or surgical intervention required.The radiopaque marker was left inside the occluded vessel.There is no additional intervention planned.

• Brand Name: TERUMO PROGREAT CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 16364556
• MDR Text Key: 309413738
• Report Number: 2243441-2022-00033
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987350718426
• UDI-Public: 04987350718426
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: MC*PV2815Y
• Device Lot Number: 211224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2023
• Distributor Facility Aware Date: 01/19/2023
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/19/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 0.018 GLIDE ADVANTAGE WIRE.; 238F TERUMO PROGREAT MICROCATHETER.; GLIDE CATHETER.; GLIDEWIRE.
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 67 KG