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	05/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the balloon (subject device) was inflated.When the balloon was attempted to deflate it was unable to deflate.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 to the manufacturer.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned, and the lot number was confirmed from the device hub.During visual inspection, the balloon was seen to be detached/separated and the catheter tip was seen to be broken/fractured.The balloon catheter shaft was seen to be stretched by the polymide and the shaft was also damaged 81cm from the hub.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 specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated there was no resistance when the guidewire was inserted.There was no friction and no resistance at the hub of the guiding catheter.A 1cc syringe was used to inflate the balloon in the body.There was no impact to the patient as a result of the event.The anatomy location (vessel name) the balloon did not deflate was the gastric artery.The device was returned for analysis and the balloon was detached/separated and the balloon catheter tip was broken/fractured.The balloon catheter shaft was stretched by the polyimide and the balloon catheter shaft was also damaged 81cm from the hub.The as reported event of balloon difficult/unable to deflate during use and the as analysed events of balloon detached/separated, balloon catheter damaged, balloon catheter tip broken/fractured during use and balloon catheter shaft stretched 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 the procedure, the balloon (subject device) was inflated.When the balloon was attempted to deflate it was unable to deflate.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: 17154423
• Report Number: 3008881809-2023-00306
• Device Sequence Number: 12183352
• 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): 08/18/2023

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: 03/06/2024
• Device Model Number: M003SRC05150
• Device Catalogue Number: M003SRC05150
• Device Lot Number: 23528718
• 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: 05/26/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 8 FR SHEATH (UNKNOWN); MICROCATHETER (LEONIS MOVA); TRANSEND GUIDEWIRE (STRYKER)
• Patient Age: 76 YR
• Patient Sex: Female