MAUDE Adverse Event Report: PULSAR VASCULAR PULSERIDER T, 3MM, 8MM ARCH; ANEURYSM NECK RECONSTRUCTION DEVICE

Catalog Number 201D

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4) information regarding patient age, gender, weight, race, ethnicity, and medical history were not provided.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by a health care professional, during a coil embolization of the internal carotid artery (ica), when the user was introducing the pulserider (201d,w3086-18), into the prowler select microcatheter (606s255fx, 17751958), the pulserider could not advance through the sheath while it was inserted into the microcatheter hub.The sales representative advised the user to retract the pulserider further back into the protective sheath and cutting the protective sheath at a 45° angle to allow it to advance into the micro catheter hub.At this point the issue was resolved.There was about an hour of procedural delay due to the troubleshooting to advance the device.However, the physician was unable to navigate the tortious anatomy to appropriately place, so the device was removed and patient was taken to surgery.The physician has reported that this was not because of device failure but because of the patient¿s anatomy.The product will be returned for analysis.The physician flush the device as directed per instructions for use (ifu).After inspecting the device and sheath, it was noticed that the introducer sheath was thicker on one side keeping the sheath from centering itself into the microcatheter.The user noted that resistance/friction occurred due to the introducer sheath being either too thin or too thick to center itself into the hub of the micro catheter.Continuous flush was maintained through all catheters during the procedure.The device was appropriately sized to the vessel.The user inspected the pulserider to make sure that it had not been damaged during the prior attempts to advance and it was intact and looked great as did the microcatheter.The device was returned with its torque device.The aneurysm neck reconstruction device (anrd, pulserider device) is located in the fep transfer sheath.The distal end of the fep transfer sheath has been cut at an angle.The cut-off end of the fep transfer sheath was not returned with the device.The anrd was advanced out of the sheath.The fork is bent.The anrd appears to be intact.The crimp connection between the delivery wire and the fork is intact.The arch is intact.Microscopic image of the cut end of the fep transfer sheath.The outer diameter (od) of the sheath was measured away from the cut end with caliper.The od was within the specification range.The sheath id measured at 0.027 inch at the distal end and 0.028 inch at the proximal end, both of which are within the specification range.The device was hydrated with saline and an attempt was made to advance it through a lab rotating hemostatic valve (rhv) and lab prowler select plus microcatheter.The cut end of the fep transfer sheath advanced all the way to the end of the luer connector.The device successfully advanced through the microcatheter.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The complaint that the pulserider could not advance through the sheath was not confirmed.The device was successfully able to advance through the sheath and a compatible lab microcatheter.The id and od of the fep transfer sheath are within documented specifications.The id of the sheath at the cut end is slightly narrower than at the other end, but this could be a result of compression caused while the end of the device was cut.It should be noted that this result agrees with the event description in that the user was able to successfully advance the anrd into and through the microcatheter after cutting the end of the fep transfer sheath at a diagonal.Without the return of the cut-off end of the fpt transfer sheath, it cannot be determined whether the distal end of the sheath contributed to the reported incident.The ifu warns that to never advance or apply torque against resistance without careful fluoroscopic assessment of the cause.Movement against resistance may result in damage to the vessel or the device.If the cause cannot be determined, withdraw the device from the patient and replace with a new device.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

Event Description

As reported by a health care professional, during a coil embolization to the internal carotid artery (ica), when the user was introducing the pulserider (201d,w3086-18), into the prowler select microcatheter (606s255fx, 17751958), the pulserider could not advance through the sheath while was inserted into the microcatheter hub.The sales representative advised the user to retract the pulserider further back into the protective sheath and cutting the protective sheath at a 45° angle to allow it to advance into the micro catheter hub.At this point the issue was resolved.There was about an hour of procedural delay due to the troubleshooting to advance the device.However, the physician was unable to navigate the tortious anatomy to appropriately place, so the device was removed and patient was taken to surgery.The physician has reported that this was not because of device failure but because of the patient¿s anatomy.The product will be returned for analysis.The physician flush the device as directed per instructions for use (ifu).After inspecting the device and sheath, it was noticed that the introducer sheath was thicker on one side keeping the sheath from centering itself into the microcatheter.The user noted that resistance/friction occurred due to the introducer sheath being either too thin or too thick to center itself into the hub of the micro catheter.Continuous flush was maintained through all catheters during the procedure.The device was appropriately sized to the vessel.The user inspected the pulserider to make sure that it had not been damaged during the prior attempts to advance and it was intact and looked great as did the microcatheter.Additional information indicated that there was no kink during pre/post procedure observation.Or when the device was being packaged to be return.

• Brand Name: PULSERIDER T, 3MM, 8MM ARCH
• Type of Device: ANEURYSM NECK RECONSTRUCTION DEVICE
• Manufacturer (Section D): PULSAR VASCULAR; 130 knowles dr suite e; los gatos 95032
• Manufacturer (Section G): PULSAR VASCULAR; 130 knowles dr suite e; los gatos CA 95032
• Manufacturer Contact: joaquin kurz ; 130 knowles dr suite e; los gatos 95032 ; 650 687-49
• MDR Report Key: 7267275
• MDR Text Key: 99939208
• Report Number: 3008680601-2018-00503
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00859030005154
• UDI-Public: 00859030005154
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201D
• Device Lot Number: W3086-18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Required Intervention