MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION TERUMO PROGREAT CATHETER; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

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.

Manufacturer Narrative

Implanted date: device was not implanted, 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.Review of the manufacturing record and the shipping inspection record of the product with the involved product code/lot# combination confirmed that there were not any indications of anomaly in them.A search of the complaint file found no other similar report of the product with the involved product code/lot# 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

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.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide additional information in section b5 and the sample receipt date in section d9.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.For the importer report, please see mdr 2243441-2022-00033.

Manufacturer Narrative

This report is being submitted as follow-up no.2 to update section h3, and to provide the completed investigation results.The actual sample was received by ashitaka factory on february 7, 2023.Follow-up is implemented based on the following investigation result.1.Visual inspection of the actual sample · distal end: it had been buckled and bent 2.Magnifying inspection of the distal end of actual sample · distal end - approximately 11.5mm from the distal end: the contrast marker was come off and was missing.Contrast marker placement mark and adhesion mark, and inner coil placement mark were found on the outer layer.· approximately 9.5mm from the distal end: distal end of the inner layer was found.· approximately 11.5mm - 15mm from the distal end: the inner coil had been buckled.· it was inferred that the inner layer and the inner coil were displaced to the hand side.· approximately 15mm or more from the distal end: red substance had been adhered to the lumen, and the inner coil had been jumbled.3.Magnifying inspection of the actual sample · approximately 15mm - 50mm from the distal end: the inner coil had been jumbled.· approximately 50mm - 100mm from the distal end: it had been flattened due to the crush.· approximately 142mm from the distal end: a hole was found.· approximately 15mm - 150mm from the distal end: red substance had been adhered to the lumen.· approximately 150mm from the distal end - rear end: no anomaly was found in its appearance.4.Component analysis of the red substance in the lumen of actual sample · the red substance was investigated by ft-ir*.The spectrum was very similar to that of casein (protein), and it was likely that the involved substance was blood clot.* ft-ir (fourier transform infrared spectroscopy): an analysis method that irradiates substances with infrared light and measures the transmitted or reflected light for structural analysis and quantitative analysis.5.Magnifying inspection of the distal end (top surface) of actual sample · only the outer layer was found in the actual sample, and no inner layer was found.6.Electron microscopic inspection of the distal end (top surface) of actual sample · the outer layer of actual sample had been flared inward.· it was inferred that some hard object came into contact with the distal end of actual sample.7.Magnifying inspection of the distal end of inner layer of the actual sample after removing the outer layer · distal end of the inner layer: contrast marker placement mark and adhesion mark were found.· it was likely that the adhesion of the contrast marker part was manufactured without any problems.· the inner coil had been buckled on the distal side.· from the buckled section to approx.50mm on the rear end side, the second coil marker and the inner coil had been unraveled.· since buckled section and unraveled section were found in the inner coil, it was presumed that compressive force and pulling force were applied.8.Magnifying inspection of the distal end (top surface) of inner layer of the actual sample after removing the outer layer · the distal end had been completely crushed and deformed.9.Electron microscopic inspection of the distal end (top surface) of inner layer of the actual sample after removing the outer layer · scratches were found in the deformed section.· it was inferred that when the inner layer was displaced to the hand side, some hard object (e.G.Lesion, damaged section of the guidewire used in combination) came into contact with the distal end.10.Confirmation of dimensions of the actual sample · outer diameter of the outer layer (normal section): it met the factory's specifications.No anomaly was found.· inner diameter of the inner layer: since the inner layer was damaged, it could not be measured.Based on the investigation result, as a possible cause of this case, the following mechanism was inferred.1.Since some hard object (e.G.Lesion, damaged section of the guidewire used in combination) came into contact with the distal end of actual sample, the outer layer was flared or scratched, resulting in a decrease in adhesion.2.Under the condition of "1", the actual sample was pushed in or the guidewire used in combination was pulled out.Due to this, the inner layer was crushed and deformed, the inner layer was lifted from the outer layer, and was caught by the guidewire, causing resistance.In addition, blood clot adhered to the lumen of actual sample, reducing the slid ability of guidewire on the inner surface, which increased resistance.3.As the same operation was continued in the condition of "2", the inner layer began to displace toward the hand side, the inner coil was buckled and the inner layer was deformed, and it got stuck with the guidewire used in combination.4.Since the inner layer of the distal end of contrast marker was deformed, the adhesion between the outer layer and the contrast marker was weakened.Subsequently, when the guidewire was pushed or flushed, it was pushed out from the distal end of actual sample and was dislodged.In addition, the actual sample was crushed at approximately 50mm and 100mm from the distal end, presumably due to the application of compressive force.It was inferred that this event flattened the product and narrowed the clearance from the lumen of actual sample, which also led to the factor of resistance in "2".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 to assure the catheter lumen.· after the product assembling process, a core wire conforming to the maximum applicable guidewire is inserted over the entire length of the catheter, and 100% insertion inspection is performed to assure that there is no anomaly in the catheter lumen.· before the product packaging process, 100% visual inspection is performed to assure that there is no crush or elongation.Ifu states: "· do not manipulate the catheter by force.The catheter tip, highly flexible, may be stretched or damaged.· if any resistance is felt while removing the guide wire, do not remove the guide wire by force.Drawing back the guide wire against resistance may cause the catheter to kink.Carefully remove the guide wire together with the catheter.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

• Brand Name: TERUMO PROGREAT CATHETER
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• 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 ; 6402040886
• MDR Report Key: 16209838
• MDR Text Key: 307767876
• Report Number: 9681834-2022-00284
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987350718426
• UDI-Public: 04987350718426
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2023

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 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2022
• Initial Date FDA Received: 01/19/2023
• Supplement Dates Manufacturer Received: 01/19/2023; 02/07/2023
• Supplement Dates FDA Received: 02/13/2023; 03/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/24/2021
• 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: 0.018 GLIDE ADVANTAGE WIRE; 2.8F TERUMO PROGREAT MICROCATHETER; GLIDE CATHETER; GLIDEWIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 67 KG