MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK EXCELSIOR SL-10 PRE-SHAPED 90 150CM; CATHETER, PERCUTANEOUS

Model Number M0031681910

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aneurysm (1708); Rupture (2208); Ruptured Aneurysm (4436)

Event Date 06/30/2020

Event Type  Injury  

Event Description

It was reported that during procedure to treat sub arachnoid hemorrhage due to aneurysm rupture, two coils were successfully placed in the aneurysm.When the third coil used, it stuck at the distal tip of the subject catheter.When attempting to dislodge stuck coil, aneurysm re-ruptured due to microwire piercing the aneurysm dome.Once the coil was dislodged, physician treated ruptured aneurysm with subject catheter and additional coiling.No surgical delay was reported, and the procedure was completed successfully.Post procedure, the patient scored a 15 on the gsc (glasgow coma scale) and was moving all limbs.

Event Description

It was reported that during procedure to treat sub arachnoid hemorrhage due to aneurysm rupture, two coils were successfully placed in the aneurysm.When the third coil used, it stuck at the distal tip of the subject catheter.When attempting to dislodge stuck coil, aneurysm re-ruptured due to microwire piercing the aneurysm dome.Once the coil was dislodged, physician treated ruptured aneurysm with subject catheter and additional coiling.No surgical delay was reported, and the procedure was completed successfully.Post procedure, the patient scored a 15 on the gsc (glasgow coma scale) and was moving all limbs.

Manufacturer Narrative

Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Device was returned for analysis, the subject catheter was returned and the lot number was confirmed with the packaging returned with device and the hub.During visual inspection, it was observed that the subject catheter was bent.The subject catheter tip and hub was intact.During functional testing, the subject device was flushed and a 0.0158¿ patency mandrel was advanced through the subject microcatheter without any resistance felt.The reported defect was not confirmed during analysis however, the analysis results are consistent with the event.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.As per the additional information, the patients anatomy was moderately tortuous and a microwire pierced the aneurysm while trying to dislodge the stuck coil in the distal tip of the microcatheter.The device was returned and the damage noted to the device is indicative of the reported event.It is probable that the device was damaged during the clinical procedure causing the reported friction.An assignable cause of procedural factors will be assigned to the reported catheter shaft friction, patient aneurysm rupture and device interaction with another device and to the analyzed catheter kinked/ bent, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in accordance with the dfu but due to procedural and/or anatomical factors during use, the device performance was limited.

• Brand Name: EXCELSIOR SL-10 PRE-SHAPED 90 150CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 10365485
• MDR Text Key: 201709289
• Report Number: 3008881809-2020-00228
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 04546540688231
• UDI-Public: 04546540688231
• Combination Product (y/n): N
• PMA/PMN Number: K042568
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2021
• Device Model Number: M0031681910
• Device Catalogue Number: M0031681910
• Device Lot Number: 21637797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/04/2020
• Supplement Dates Manufacturer Received: 09/29/2020
• Supplement Dates FDA Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CERENOVOUS MICROCOIL (JOHNSON & JOHNSON); DELTAFILL COIL (JOHNSON & JOHNSON); TARGET DETACHABLE COIL (STRYKER)
• Patient Outcome(s): Other; Required Intervention