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

Model Number	M003SSC07070
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not received yet for evaluation.
Event or Problem Description
It was reported that during the procedure, the balloon (subject device) ruptured.The patients medical condition was good and the procedure was completed successfully.There were no clinical consequences to the patient.
Additional Manufacturer Narrative
The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Although the dhr could not be reviewed because the lot number remains unknown, there are controls in the manufacturing process to ensure the product met specifications upon release.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 there was no damage noted to the packaging and no anomalies were noted to the device prior to use.While the device was prepared as per the dfu and the correct inflation medium was used to inflate the balloon as per the dfu, it may have been overinflated prior to use.The balloon was able to be successfully inflated during preparation and no leak was noted but the balloon ruptured during use.An encephalotor device was use to inflate the balloon.Continuous flush was maintained.It was unknown how tortuous was the patient¿s anatomy.The dfu requests using a 3cc syringe, to inflate the balloon with the contrast mixture to the nominal recommended inflation volume (refer to the compliance chart) and inspect the balloon for any surface abnormalities and air bubbles.It is most probable the use of the encephalotor device resulted in the balloon rupturing during use.An assignable cause of ¿user error¿ will be assigned to reported balloon burst/ruptured during use, as the additional information confirmed that there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer and/or expected by the user.H3 other text : device not returned for evaluation.
Event or Problem Description
It was reported that during the procedure, the balloon (subject device) ruptured.The patients medical condition was good and the procedure was completed successfully.There were no clinical consequences to the patient.

• Brand Name: TRANSFORM SUPER COMPLIANT 7MM 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: 11508504
• Report Number: 3008881809-2021-00126
• Device Sequence Number: 4087790
• Product Code: MJN
• UDI-Device Identifier: 07613327004700
• UDI-Public: 07613327004700
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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): 06/28/2021

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: Health Professional
• Device Model Number: M003SSC07070
• Device Catalogue Number: M003SSC07070
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1