MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TRANSFORM COMPLIANT 4MM X 15MM - US; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number	M003SRC04150
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the physician attempted to post dilate a flow diverting stent.The subject balloon catheter was prepped and tested on the back table.When the subject balloon was inflated inside the patient's body at right distal ica/mca, it would not inflate.The subject balloon was noted to be torn and got damaged during the placement through a catheter and the flow diverting stent.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the balloon catheter was noted to have dried blood at the balloon site.A tear/hole was noted at the distal side of the proximal marker band and there were no other anomalies noted with the device.During functional inspection, an unsuccessful attempt was made to flush the catheter.A patency mandrel was advanced through the catheter, a blockage was noted at the balloon site due to dried blood, the catheter was soaked in warm water and another attempt was made with the mandrel successfully.The catheter was flushed in an attempt to inflate the balloon, it did not inflate, the water leaked through the hole above the proximal marker band.The reported complaint was confirmed based on analysis.The device failed to meet specification when received for complaint investigation based on the analyzed anomalies noted to the device.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 issue with the guidewire used with the device since it worked perfectly fine with new balloon.The correct 50/50 % contrast inflation media was used during preparation and procedure to inflate the balloon.The anatomy location (vessel name) the balloon did not inflate was the right distal ica/mca.The tip of the guidewire was distal in relation to the tip of the balloon catheter.The lumen of the catheter was flushed through with heparinized saline.The balloon never inflated.The device was not inflated over nominal pressure and no excessive pressure was used.There was no leakage noted during preparation or procedure.In the physician¿s opinion the cause of the leak and rupture was due to balloon must have torn during placement thru 2 pipeline and 1 evolve device.They never retested the balloon outside body to verify.The as reported and as analyzed balloon failed to inflate and balloon burst/ruptured during use in addition to the as reported device interaction with another device 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 physician attempted to post dilate a flow diverting stent.The subject balloon catheter was prepped and tested on the back table.When the subject balloon was inflated inside the patient's body at right distal ica/mca, it would not inflate.The subject balloon was noted to be torn and got damaged during the placement through a catheter and the flow diverting stent.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TRANSFORM COMPLIANT 4MM 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: priya niroula ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 12460374
• Report Number: 3008881809-2021-00374
• Device Sequence Number: 4815124
• Product Code: MJN
• UDI-Device Identifier: 07613327004434
• UDI-Public: 07613327004434
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 01/11/2022

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: 10/06/2021
• Device Model Number: M003SRC04150
• Device Catalogue Number: M003SRC04150
• Device Lot Number: 21806219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 12/28/2021
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2019
• 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: EVOLVE FLOW DIVERTER (STRYKER); PIPELINE CATHETER (MEDTRONIC); SYNCHRO GUIDEWIRE (STRYKER); EVOLVE FLOW DIVERTER (STRYKER); PIPELINE CATHETER (MEDTRONIC); SYNCHRO GUIDEWIRE (STRYKER)
• Patient Sex: Male