MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TRANSFORM SUPER COMPLIANT 4MM X 7MM - US; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number	M003SSC04070
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure when the balloon catheter (subject device) was attempted to inflate inside the body, the balloon broke and it could not inflate.The subject balloon catheter fragment was completely removed from the patient¿s anatomy without a snare.The physician replaced it with a new device, and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
D4 expiration date added.H4 manufacturing date added.H3 device evaluated by mfg updated.H3 summary attached updated.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual/microscopic inspection: the balloon catheter hub was inspected, and crystalized procedural fluid most likely saline-contrast mixture was present.The balloon catheter shaft was inspected and a tear was visible on the chronoprene balloon.Functional test: a demonstration guidewire was inserted into the balloon catheter hub but it could not be advanced due to crystalised procedural fluid.The balloon catheter shaft was cut at the distal end to check the balloon inflation.The balloon did not inflate and a leak was noted.The chronoprene balloon was damaged.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.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, no abnormalities were found when the balloon was expanded outside the body (air, leaks, or poor expansion), continuous flush was set up and maintained throughout the clinical procedure, no resistance was encountered when the guidewire was inserted, and a 1cc syringe was used to inflate the balloon with 75% contrast agent.During analysis, the balloon catheter hub was inspected and crystallized procedural fluid (most likely saline-contrast mixture) was present.A patency test was unable to be performed due to the presence of the solidified saline-contrast mixture in the hub and balloon catheter shaft.It is likely that the contrast solidified inside the hub and lumen over time post procedure.The balloon catheter shaft was cut at the distal end to check balloon inflation.The balloon was unable to be inflated and a leak was noted on the chronoprene balloon which had a visible tear.In the case of this complaint, it is probable that the chronoprene balloon was damaged during manipulation inside the patient which resulted in the reported inflation failure.Therefore, the reported event was confirmed.The as reported balloon catheter broken/fractured during use was not confirmed as the balloon catheter shaft was torn at the chronoprene balloon and not fractured.An assignable cause of procedural factors will be assigned to the as analyzed balloon catheter shaft blocked/occluded balloon catheter damaged, balloon catheter shaft leaked during use and balloon failed to inflate since these issues are 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 and/or anatomical factors during use.
Event or Problem Description
It was reported that during the procedure when the balloon catheter (subject device) was attempted to inflate inside the body, the balloon broke and it could not inflate.The subject balloon catheter fragment was completely removed from the patient¿s anatomy without a snare.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TRANSFORM SUPER COMPLIANT 4MM X 7MM - US
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11009222
• Report Number: 3008881809-2020-00392
• Device Sequence Number: 3823235
• Product Code: MJN
• UDI-Device Identifier: 07613327004694
• UDI-Public: 07613327004694
• 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): 03/16/2021

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: No Information
• Device Expiration Date: 03/08/2022
• Device Model Number: M003SSC04070
• Device Catalogue Number: M003SSC04070
• Device Lot Number: 22177916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1