MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TRANSFORM COMPLIANT 5MM X 15MM - US; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number	M003SRC05150
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during coil embolization of celiac aneurysm the occlusion balloon catheter (subject device) was advanced to the target site after setup.When inflation and deflation were performed, it was noted that both motions were slow.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
The device is not available.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection dried procedural fluid was noted inside the balloon and balloon catheter hub.The balloon catheter shaft was noted to be kinked/bent 25cm from the hub.There were no other visual anomalies noted to the device.During functional inspection an unsuccessful attempt was made to flush the device; a balloon was partially inflated and could not be deflated.An attempt was made to pass a demonstration guide wire through the device, but resistance was met at the kinked section of the catheter shaft.The balloon catheter was cut in order to inflate the balloon, but with no success as the demo guidewire could not be advanced through due to the buildup of a dried procedural fluid.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The reported complaint was confirmed based on analysis.The device failed to meet specification when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that there was no damage noted to the packaging prior to opening the packaging, the device was prepared for use as per the dfu, the device was confirmed to be in good condition during preparation/prior to use on the patient, flush was given when the subject balloon was taken out from the dispenser hoop, the entire system was flushed with a saline-contrast mixture, the correct inflation medium was used to inflate the balloon as per the dfu, there was no resistance when the guidewire (gw) was inserted and after the gw was inserted, the entire system was flushed, and saline-contrast mixture confirmed it flowed.Continuous flush was set up and maintained throughout the clinical procedure.No friction or resistance was felt at the hub of the guiding catheter.A 1cc syringe was used to inflate the balloon in the body.It is unknown if the device was inflated over nominal pressure or if excessive pressure was used.The contrast agent was diluted at a percentage of 75%.The size of the concomitantly used gw was 0.014¿.There were no abnormalities such as air, leaks, or poor expansion when the balloon was expanded outside the body.It¿s unknown how tortuous was the patient¿s anatomy.The device was returned for analysis and the balloon catheter hub and shaft were found to be blocked/occluded due to dried procedural fluid.The balloon catheter shaft was also noted to be kinked/bent 25cm from the hub.An unsuccessful attempt was made to flush the device due to the dried procedural fluid.While the balloon was partially inflated it could not be deflated.An attempt was made to pass a demonstration guide wire through the device, but resistance was met at the kinked section of the catheter shaft.The balloon catheter was cut in an attempt to fully inflate the balloon, but without success as the demo guidewire could not be advanced through due to the build-up of a dried procedural fluid.While additional information states continuous flush was maintained it was most likely insufficient to prevent procedural fluids entering the device, which would have contributed to the difficulty experienced inflating and deflating the device during the procedure.These procedural fluids had solidified inside the device during transit back to the manufacturing site as noted during product analysis.The as reported and as analyzed ¿balloon difficult/unable to deflate during use¿ and ¿balloon difficult to inflate¿ in addition to the as analyzed 'balloon catheter shaft blocked/occluded' and 'balloon catheter kinked/bent' will be assigned procedural factors as these defects appear to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural or anatomical factors during use.
Event or Problem Description
It was reported that during coil embolization of celiac aneurysm the occlusion balloon catheter (subject device) was advanced to the target site after setup.When inflation and deflation were performed, it was noted that both motions were slow.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TRANSFORM COMPLIANT 5MM X 15MM - US
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 16546197
• Report Number: 3008881809-2023-00128
• Device Sequence Number: 6472001
• Product Code: MJN
• UDI-Device Identifier: 07613327004472
• UDI-Public: 07613327004472
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122576
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/07/2024
• Device Model Number: M003SRC05150
• Device Catalogue Number: M003SRC05150
• Device Lot Number: 23528719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown