MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY MERCI BGC 8F X 95CM; CATHETER, PERCUTANEOUS

Model Number	90073
Medical Device Problem Codes	Deflation Problem (1149); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not received for evaluation.
Event or Problem Description
It was reported that during the procedure while inflating the balloon (subject device), the contrast medium was leaking into the vessel.The subject balloon had difficulty deflating inside the patient¿s anatomy.There were no clinical consequences reported to the patient due to this event.
Additional Manufacturer Narrative
The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.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.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.
Event or Problem Description
It was reported that during the procedure while inflating the balloon (subject device), the contrast medium was leaking into the vessel.The subject balloon had difficulty deflating inside the patient¿s anatomy.There were no clinical consequences reported to the patient due to this event.
Additional Manufacturer Narrative
The device was returned with no packaging.During visual inspection there were no visual anomalies noted to the device.During the functional inspection an attempt was made to aspirate and inflate the balloon.The balloon was partially inflated with air and was unable to be fully inflated or deflated.There was crystalized contrast media noted within the partially inflated balloon.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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 reported event of the balloon unable to deflate was confirmed based on analysis.The reported event of the balloon leaking was not confirmed.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that when inflating the balloon, contrast medium was leaking into the vessel and deflation took an unusually long time.During analysis, no visual anomalies were noted to the device.An attempt was made to aspirate and inflate the balloon.The balloon was partially inflated with air and was unable to be fully inflated or deflated.There was crystalized contrast media noted within the partially inflated balloon.It is probable that difficulty with inflation and deflation may have been due to the presence of dried contrast within the inflation lumen.An assignable cause of procedural factors will be assigned to the balloon unable to deflate since these issues 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 and/or anatomical factors during use.No leaks were noted during analysis.Therefore, not confirmed will be assigned to the balloon leaking during use since this 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.
Event or Problem Description
It was reported that during the procedure while inflating the balloon (subject device), the contrast medium was leaking into the vessel.The subject balloon had difficulty deflating inside the patient¿s anatomy.There were no clinical consequences reported to the patient due to this event.

• Brand Name: MERCI BGC 8F 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
• MDR Report Key: 10341250
• Report Number: 3012931345-2020-00111
• Device Sequence Number: 3484887
• Product Code: DQY
• UDI-Device Identifier: 00815742000733
• UDI-Public: 00815742000733
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K112404
• 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,Followup
• Report Date (Section B): 02/25/2021

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: 06/30/2020
• Device Model Number: 90073
• Device Catalogue Number: 90073
• Device Lot Number: 0000009394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 10/14/2020; 02/24/2021
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 11/03/2020; 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1