MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TRANSFORM COMPLIANT 4MM X 10MM - US; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number	M003SRC04100
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the subject balloon ruptured during use.The procedure was completed successfully without clinical consequence to the patient.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes), there are controls in the manufacturing process to ensure the product met specifications upon release.On initial inspection, the device was returned in the introducer sheath.The lot number was confirmed from the hub and the returned packaging.On visual/ microscopic inspection, the balloon catheter hub was inspected and no anomaly was noted.The balloon catheter shaft was was kinked 82.5cm from the proximal end.On functional testing, it was not possible to advance the demonstration 0.014¿ guidewire through the kinked shaft therefore the shaft was cut approximately 10cm from the distal end in order to advance the guide wire to perform the inflation test.The device was inflated without difficulty and there were no leaks noted to the inflated balloon.The reported event was not confirmed based on product analysis.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 there was no damage noted to the packaging, there were no anomalies noted to the device prior to use, the device was prepared as per the dfu, continuous flush was maintained and the patient¿s anatomy was not tortuous.The device was not inflated over nominal pressure or excessive pressure used.The balloon was not able to be successfully inflated during preparation, a syringe was used to inflate the balloon and the correct inflation medium was used to inflate the balloon as per the dfu.The balloon was damaged and had popped (burst/ruptured) during preparation.Another transform device was used to complete the procedure.The device was returned for analysis and the as reported ¿balloon burst/ruptured during preparation¿ was not confirmed as there was no anomaly with the balloon and it was inflated without issue.The device was severely kinked 82.5cm from the proximal end which most likely occurred during preparation of the device.The as analyzed ¿balloon catheter kinked/bent¿ will be assigned handling damage as the issue is due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that during the procedure, the subject balloon ruptured during use.The procedure was completed successfully without clinical consequence to the patient.Additional information was received that the subject balloon catheter had burst during preparation outside the patient.No clinical consequences were reported to the patient due to this event.

• Brand Name: TRANSFORM COMPLIANT 4MM 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
• MDR Report Key: 11122127
• Report Number: 3008881809-2021-00009
• Device Sequence Number: 13664441
• Product Code: MJN
• UDI-Device Identifier: 07613327004441
• UDI-Public: 07613327004441
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 03/30/2021

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 Expiration Date: 06/30/2022
• Device Model Number: M003SRC04100
• Device Catalogue Number: M003SRC04100
• Device Lot Number: 22320668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1