MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TRANSFORM COMPLIANT 4MM X 20MM - US; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Model Number	M003SRC04200
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that the balloon (subject device) would not deflate during procedure at intracranial aneurysm.Physician used a second balloon to deflate the original one that was not deflating.The procedure did not complete successfully.Patient reported to have passed away on (b)(6) 2021.Relationship of patient death to the balloon (subject device) and associated procedure is unknown.No other information was provided.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, two transform devices were returned, multiple pieces of procedural equipment were returned with device.It was noted that the lamination over the vents on device (b)(6) was damaged, it was noted that the vent section of device (b)(6) was filled with blood, and it was noted that both devices were returned with synchro guidewires within.A functional inspection could not be completed on either device due as the synchro devices were stuck in the catheters.An attempt was made to flush the devices unsuccessfully, they were then soaked for 2 hours in warm water without success.The reported event could not be confirmed; however, the analysis results are consistent with the reported event.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 direction 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, continuous flush was maintained to the device per the dfu.It was unknown how tortuous the patient¿s anatomy was, what device was used to inflate the balloon, whether the correct inflation medium used to inflate the balloon as per the dfu, was the device inflated over nominal pressure or excessive pressure used or was the balloon successfully inflated during preparation.Additional information indicates that it is unknown what caused the patient¿s death.Two devices were returned for analysis and the balloon catheter shafts were noted to be ¿balloon damaged¿ and ¿balloon catheter shaft blocked/occluded¿.The catheter shafts were damaged and blocked/occluded which can lead to balloon deflation issues.It is probable that the damage and blood with the device caused the failure to deflate.The as reported defect ¿balloon difficult/unable to deflate during use¿ and ¿patient death¿ in addition to the as analyzed defects ¿balloon damaged¿ and ¿balloon catheter shaft blocked/occluded¿ 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 the balloon (subject device) would not deflate during procedure at intracranial aneurysm.Physician used a second balloon to deflate the original one that was not deflating.The procedure did not complete successfully.Patient reported to have passed away on (b)(6) 2021.Relationship of patient death to the balloon (subject device) and associated procedure is unknown.No other information was provided.

• Brand Name: TRANSFORM COMPLIANT 4MM X 20MM - 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: 12278627
• Report Number: 3008881809-2021-00326
• Device Sequence Number: 11912109
• Product Code: MJN
• UDI-Device Identifier: 07613327004458
• UDI-Public: 07613327004458
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2021

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 Model Number: M003SRC04200
• Device Catalogue Number: M003SRC04200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: SYNCHRO WIRE (STRYKER MANUFACTURER); TRANSFORM (STRYKER); TRANSFORM 3X10 (STRYKER MANUFACTURER); SYNCHRO WIRE (STRYKER MANUFACTURER); TRANSFORM 3X10 (STRYKER MANUFACTURER)
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown