MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK XT-17 STANDARD STRAIGHT; CATHETER, PERCUTANEOUS

Catalog Number M003C1775ST0

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2017

Event Type  malfunction  

Manufacturer Narrative

The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.During the analysis of the returned device, it was revealed that a hole was noted on the catheter shaft distal end.During the functioning test, it was found that resistance noted when advancing the mandrel through the lumen due to the damage at the distal end.And procedural fluid was expelled from the catheter during flush.Per additional information received, no anomalies were noted to the device prior to use.The anatomy was noted to be severely tortuous which is likely to have contributed to the reported event.The hole noted in the microcatheter during analysis is likely to have been caused during the attempt to push the coil out of the microcatheter with the guidewire.The communication log indicates intermittent flush was used which is consistent with the blood noted in the microcatheter during analysis.As per the dfu "caution: in order to achieve optimal performance of stryker neurovascular microcatheters and to maintain the lubricity of the hydrolene® coating surface, it is critical that a continuous flow of appropriate flush solution be maintained between the stryker neurovascular microcatheter and guide catheter, and the microcatheter and any intraluminal device.In addition, flushing aids in preventing contrast crystal formation and/or clotting on both the intraluminal device and inside the guide catheter and/or the microcatheter lumen".Therefore an assignable cause of use error caused or contributed to event will be assigned to the 'catheter shaft has hole/perforation' and 'catheter friction'.As the investigation confirms that there was an act or omission of an act that resulted in a different medical product response than intended by the manufacturer and/or expected by the user.

Event Description

During the analysis of the returned device, it was revealed that a hole was noted on the catheter shaft distal end.No clinical consequences reported to the patient.

• Brand Name: XT-17 STANDARD STRAIGHT
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 7151726
• MDR Text Key: 96124963
• Report Number: 3008881809-2017-00551
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K142565
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: M003C1775ST0
• Device Lot Number: 19496584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR