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	Material Rupture (1546)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	05/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the anterior cerebral artery procedure, the balloon (subject device) ruptured inside the patient's anatomy.Also, the patient blood vessel was ruptured.No further information available about the procedure and patient condition.
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Additional Manufacturer Narrative
Due to the automated mes system, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot be performed.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.It was reported that the subject balloon ruptured inside the patient.Additional information provided by the customer indicated that no anomalies were noted to the device prior to preparation, the device was prepared as per the dfu, 50% contrast was used during preparation and procedure, continuous flush was maintained throughout the procedure, and the patient anatomy was moderately tortuous.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable was assigned to this complaint.
Event or Problem Description
It was reported that during the anterior cerebral artery procedure, the balloon (subject device) ruptured inside the patient's anatomy.Also, the patient blood vessel was ruptured.No further information available about the procedure and patient condition.

• 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
• 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: 14675022
• Report Number: 3008881809-2022-00289
• Device Sequence Number: 12115104
• Product Code: MJN
• UDI-Device Identifier: 07613327004694
• UDI-Public: 07613327004694
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/02/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/13/2024
• Device Model Number: M003SSC04070
• Device Catalogue Number: M003SSC04070
• Device Lot Number: 22644195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 08/11/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 09/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown