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	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the subject occlusion balloon was unable to deflate inside the patient.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
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 the visual inspection, the subject balloon catheter shaft was noted to be kinked/bent at 22.2cm and 24.8cm from the proximal end.The balloon catheter shaft was noted to flattened/crushed at 146cm from the proximal end.The ldpe/lldpe and chloroprene were torn at the distal end of the balloon catheter.The balloon was noted to be damaged.During the functional inspection, an attempt was made without success to flush the device.A patency mandrel was advanced through the balloon catheter but would not go beyond the first marker band due to damage.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.A 3cc syringe was used to inflate the balloon, the correct inflation medium was used to inflate the balloon as per the dfu, the device was not over inflated over nominal pressure or excessive pressure used, the balloon was able to be successfully inflated/deflated during preparation, there was no leakage noted during preparation, a subject balloon was being treated with the stent, the anatomical location of the treatment site was the ica, a different type of stent was used in conjunction with the subject balloon and the procedure was completed successfully.The as reported and as analysed balloon difficult/unable to deflate during use, in addition to the as analysed, balloon catheter kinked/bent, balloon catheter flat/crushed, balloon catheter damaged and balloon damaged 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 subject occlusion balloon was unable to deflate inside the patient.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• 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: 12610886
• Report Number: 3008881809-2021-00423
• Device Sequence Number: 14458944
• Product Code: MJN
• UDI-Device Identifier: 07613327004519
• UDI-Public: 07613327004519
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2021

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: 06/01/2023
• Device Model Number: M003SSC07100
• Device Catalogue Number: M003SSC07100
• Device Lot Number: 22954927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2021
• 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 STENT (STRYKER)
• Patient Sex: Unknown