MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TRANSFORM SUPER COMPLIANT 7MM X 10MM- US; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number	M003SSC07100
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	10/28/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during a procedure the operator attempted to deliver the flow diverter stent to the target lesion using the subject balloon.The subject balloon was not prepared and tested according to the directions for use before using it in the patient.After the subject balloon reached the target lesion it was inflated using 100% contrast media.During inflation even before the subject balloon could reach the optimal amount of inflation, it burst inside the patient's vascular anatomy.The subject balloon was withdrawn from the patient vascular anatomy.A neurological test was conducted on the patient, approximately three hours after the surgery (after the patient woke-up from anesthesia).It was assessed that the patient suffered scotoma (blurred vision- and patchiness in eye).According to the physician the subject balloon was defective and this was the cause of the rupture.The subject balloon was replaced with another device and the procedure was completed successfully.
Event or Problem Description
It was reported that during a procedure the operator attempted to deliver the flow diverter stent to the target lesion using the subject balloon.The subject balloon was not prepared and tested according to the directions for use before using it in the patient.After the subject balloon reached the target lesion it was inflated using 100% contrast media.During inflation even before the subject balloon could reach the optimal amount of inflation, it burst inside the patient's vascular anatomy.The subject balloon was withdrawn from the patient vascular anatomy.A neurological test was conducted on the patient, approximately three hours after the surgery (after the patient woke-up from anesthesia).It was assessed that the patient suffered scotoma (blurred vision- and patchiness in eye).According to the physician the subject balloon was defective and this was the cause of the rupture.The subject balloon was replaced with another device and the procedure was completed successfully.
Additional Manufacturer Narrative
D4 expiration date - added.H4 manufacturing date ¿ added.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 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.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 during inflation inside of a stent.Additional information does not indicate any issues noted during unpacking or set up of the device, and the device was prepared as per dfu instructions.While there are a number of potential causes for the reported issue of balloon burst/ruptured during use and patient neurological deficit, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.

• Brand Name: TRANSFORM SUPER COMPLIANT 7MM X 10MM- 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: 12873437
• Report Number: 3008881809-2021-00493
• Device Sequence Number: 19960633
• Product Code: MJN
• UDI-Device Identifier: 07613327004519
• UDI-Public: 07613327004519
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/21/2022

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: 05/09/2023
• Device Model Number: M003SSC07100
• Device Catalogue Number: M003SSC07100
• Device Lot Number: 22911510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2021
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 11/25/2021
• Supplement Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SURPASS EVOLVE FLOW DIVERTER STENT (STRYKER)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female