MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR XT-27 FLEX PRE-SHAPED 150CM; CATHETER, PERCUTANEOUS

Model Number	M003XT2750920
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that during the procedure, the subject micro catheter opened in the transition between the hydrophilic part and the proximal part when advancing the flow diversion.The flow diversion partially exited through this opening and not through the natural lumen.No other information is available.
Additional Manufacturer Narrative
Updated d9 returned to manufacturer on ¿updated due to the automated manufacturing execution system (mes), there are controls in the manufacturing process to ensure the product met specifications upon release.On initial inspection, the device was returned with a non-stryker flow diverter.The lot number was confirmed with the packaging returned with the device and the hub.On visual inspection, the catheter shaft was broken and returned in two parts.The catheter was broken.The catheter shaft was twisted.The catheter shaft was flat/crushed.The catheter hub was intact.On functional inspection, the catheter was flushed and a 0.0265" patency mandrel was advanced through the two parts of the microcatheter without any resistance felt.The reported defect was not confirmed during analysis however, the analysis results are consistent with the event.The as analyzed catheter shaft broken/fractured during use, catheter shaft twisted, & catheter shaft flat/crushed will be assigned to the investigation.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 received from the customer indicated that resistance was felt during the procedure which may have caused the damage to the xt27 microcatheter.It can be presumed that the catheter was damaged during the procedure as force may have been applied when the resistance was felt.This complaint appears 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 factors during use.
Event or Problem Description
It was reported that during the procedure, the subject micro catheter opened in the transition between the hydrophilic part and the proximal part when advancing the flow diversion.The flow diversion partially exited through this opening and not through the natural lumen.No other information is available.

• Brand Name: EXCELSIOR XT-27 FLEX PRE-SHAPED 150CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11015355
• Report Number: 3008881809-2020-00396
• Device Sequence Number: 16807132
• Product Code: DQY
• UDI-Device Identifier: 04546540698162
• UDI-Public: 04546540698162
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K113778
• 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): 02/03/2021

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: 10/14/2022
• Device Model Number: M003XT2750920
• Device Catalogue Number: M003XT2750920
• Device Lot Number: 21866332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 02/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FLOW DIVERTER (UNKNOWN)