MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY MERCI BGC 9F X 95CM; CATHETER, PERCUTANEOUS

Catalog Number	90074
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that the subject balloon catheter was found to be leaking during the procedure.No further information available.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.D4 expiration date - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection there was some scraping and damage noted to the outer surface of the balloon catheter, it cannot be determined if this caused a leak to the balloon catheter shaft as the balloon could not be inflated.During functional test an attempt was made to inflate the balloon however it was unable to be inflated.The balloon was soaked in warm water for 15 minutes and another attempt was made to inflate the balloon.However, it was still unable to be inflated.The balloon catheter was damaged during the attempt to inflate due to too much pressure being applied.The balloon catheter shaft was cut to determine if there was an occlusion within the inflation lumen, no observations could be made.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.The as reported event 'balloon failed to inflate' was confirmed during inspection.The second reported event 'balloon leaked during use' could not be duplicated as the balloon could not be inflated.The analysis results are consistent with the reported event.The device did not meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information received from the customer indicates that the device was inflated using a 3ml syringe ['what device was used to inflate the balloon? 3 ml syringe'].This is not the recommended inflation device as there is a risk of over-inflating the balloon and causing it to burst.The balloon was successfully inflated during preparation using 50% contract media ['was the balloon successfully inflated/deflated during preparation? yes.What percentage of contrast was used during preparation? 50%].The customer reported on the 'impossibility of inflating the balloon without it deflating when the catheter is removed.Through which the liquid escapes'.The balloon catheter was returned for analysis.The only visible damage observed was some surface damage noted to the outer surface of the balloon catheter.An unsuccessful attempt was made to inflate the balloon.It is possible that there was some dried contrast present in the inflation pathway from the inflation completed by the user during preparation.Soaking the subject device in warm water in the complaints laboratory did not resolve (dissolve) this.An assignable cause of procedural factors has been assigned to the reported events: 'balloon leaked during use' and 'balloon failed to inflate' and the analyzed events: 'balloon failed to inflate' and 'balloon catheter damaged' as this complaint appears to be associated with a product that met the manufacturers design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during preparation/use.
Event or Problem Description
It was reported that the subject balloon catheter was found to be leaking during the procedure.No further information available.

• Brand Name: MERCI BGC 9F X 95CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 19252030
• Report Number: 3012931345-2024-00078
• Device Sequence Number: 17975163
• Product Code: DQY
• UDI-Device Identifier: 00815742000740
• UDI-Public: 00815742000740
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112404
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024

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: 09/24/2024
• Device Catalogue Number: 90074
• Device Lot Number: 0000184780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/03/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2022
• 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: CATHETER (UNKNOWN)
• Patient Sex: Unknown