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

Catalog Number	M003SSC04100
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject balloon was used in a design validation study.During this testing the subject balloon burst immediately after first inflation in the simulation model and so was replaced.
Additional Manufacturer Narrative
2/2 reports.
Event or Problem Description
It was reported that the subject balloon was used in a design validation study.During this testing the subject balloon burst immediately after first inflation in the simulation model and so was replaced.
Additional Manufacturer Narrative
B1 adverse event/product problem - corrected - no product problem.H1 type of reportable event - corrected - no malfunction.D9 product available to stryker- updated.D9 returned to manufacturer on- updated.H3 device evaluated by mfg ¿updated.Due to the automated manufacturing execution system (mes) system 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 with the packaging returned with the device.During visual inspection, there were no visual anomalies noted to the returned subject balloon device.During functional inspection, the device was flushed and a demonstration guidewire was advanced without difficulties.The balloon was then inflated and deflated without any issues.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.The reported complaint was not confirmed based on analysis.The device met specification when received for complaint investigation.Additional information provided by the customer indicated the correct inflation medium was used to inflate the balloon as per the dfu.A 3ml syringe was used to inflate the balloon.The device was inflated to nominal pressure.The balloon was able to be successfully inflated/deflated during preparation.70% contrast was used.There was no resistance encountered during the guidewire insertion and no resistance encountered during inserting the balloon through catheter.The catheter was flushed to facilitate guidewire insertion.The device was returned for analysis and no visual anomalies were noted with the returned subject balloon device.The balloon catheter was flushed and a demonstration guidewire was advanced to the distal tip without difficulties.The balloon was then inflated and deflated without any issues.The as reported event of balloon burst/ruptured during use was not confirmed during product analysis.Since the issue included a returned product review (visual, physical, and/or performance testing) which showed no evidence of either the alleged issue(s) or any defect which could have contributed to the event, an assignable cause of not confirmed will be assigned to the as reported event of balloon burst/ruptured during use.The as analyzed event of device within specifications will be assigned to this investigation.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• Brand Name: TRANSFORM SUPER 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
• 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: 19133972
• Report Number: 3008881809-2024-00170
• Device Sequence Number: 17323960
• Product Code: MJN
• UDI-Device Identifier: 07613327004502
• UDI-Public: 07613327004502
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/13/2024

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: 04/10/2024
• Device Catalogue Number: M003SSC04100
• Device Lot Number: 23593031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2022
• 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: TRANSEND EX GUIDEWIRE (STRYKER).
• Patient Sex: Unknown