MAUDE Adverse Event Report: PULSAR VASCULAR PULSERIDER T, 3MM, 8MM ARCH; INTRACRANIAL NEUROVASCULAR STENT

Model Number 201-D

Device Problems Difficult or Delayed Positioning (1157); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It was reported that the device would be returned for analysis; however, the device was not returned.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a healthcare professional, during treatment of a basilar apex aneurysm, the physician had difficulty positioning the pulserider ((b)(4)), and during removal, it did not pull back into the 021¿ prowler select plus microcatheter ((b)(4)) and both devices were removed.The neck width was 7.92mm, parent vessel diameter was 3.04mm, and implant arch width was 10 t.The prowler select plus had been advanced through the 5f chapereon 90cm guide catheter into the right vertebral artery and the pulserider was positioned into the basilar artery at the neck of the aneurysm.The device was re-positioned and pulled back into the prowler select plus twice.The decision was made to remove the device and use another pulserider shape; however, the physician had trouble pulling the device back into the catheter entirely.The pulserider and microcatheter were both removed without incident or need for intervention.The target vessel was moderately tortuous.The devices had been prepped and used as per the instruction for use (ifu).There had been no resistance between the pulserider and prowler during advancement and the device had not been torqued against resistance.A constant flush had been maintained through the microcatheter.The patient was discharged.It was reported that the devices would be returned for analysis.

Manufacturer Narrative

Product complaint # (b)(4).Conclusion: as reported by a healthcare professional, during treatment of a basilar apex aneurysm, the physician had difficulty positioning the pulserider (201d/w308607), and during removal, it did not pull back into the 021¿ prowler select plus microcatheter (606s252/ 17676317) and both devices were removed.The neck width was 7.92mm, parent vessel diameter was 3.04mm, and implant arch width was 10 t.The prowler select plus had been advanced through the 5f chapereon 90cm guide catheter into the right vertebral artery and the pulserider was positioned into the basilar artery at the neck of the aneurysm.The device was re-positioned and pulled back into the prowler select plus twice.The decision was made to remove the device and use another pulserider shape; however, the physician had trouble pulling the device back into the catheter entirely.The pulserider and microcatheter were both removed without incident or need for intervention.The target vessel was moderately tortuous.The devices had been prepped and used as per the instruction for use (ifu).There had been no resistance between the pulserider and prowler during advancement and the device had not been torqued against resistance.A constant flush had been maintained through the microcatheter.The patient was discharged.It was reported that the devices would be returned for analysis.A non-sterile prowler select plus 150/15cm was received coiled inside of a pouch.Inside of it was found stuck a pulserider device.The received microcatheter was inspected and it was found compressed at 1 and 3cm from the distal end.The received microcatheter was inspected under microscope and it was found compressed.An x-ray was performed on the received device and a pulserider device can be observed stuck in the compressed section noted on the received microcatheter.The id from the microcatheter was measured and was found within specification (hub id.021¿ specification:.021¿ minimum, distal id.021¿ specification:.021¿ minimum).The functional analysis cannot be performed since the stuck device cannot be removed from the microcatheter.During the review of the lot 17676317 it was noted that 5 units were rejected due to the defect ¿scrunch¿ and they could be related to the reported complaint.However, the dhr review confirmed that the rejected units were properly segregated and discarded.No other issues were noted that were considered potentially related to the reported complaint.The resistance was confirmed and appears to have been related to the compressed section noted on the received device.The cause of the compressed condition was apparently caused by applying excessive force on the catheter, but it could not be conclusively determined.Additionally, inspections are in place that prevents this kind of failure from leaving the facility.Procedural factors and handling process may contribute to the failure as reported.There are no current safety signals identified related to the reported events based on review of complaint histories for the devices.Since there was no evidence to suggest the events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

Manufacturer Narrative

(b)(4).As reported by a healthcare professional, during treatment of a basilar apex aneurysm, the physician had difficulty positioning the pulserider (201d/w308607), and during removal, it did not pull back into the 021¿ prowler select plus microcatheter (606s252/17676317) and both devices were removed.The neck width was 7.92mm, parent vessel diameter was 3.04mm, and implant arch width was 10 t.The prowler select plus had been advanced through the 5f chapereon 90cm guide catheter into the right vertebral artery and the pulserider was positioned into the basilar artery at the neck of the aneurysm.The device was re-positioned and pulled back into the prowler select plus twice.The decision was made to remove the device and use another pulserider shape; however, the physician had trouble pulling the device back into the catheter entirely.The pulserider and microcatheter were both removed without incident or need for intervention.The target vessel was moderately tortuous.The devices had been prepped and used as per the instruction for use (ifu).There had been no resistance between the pulserider and prowler during advancement and the device had not been torqued against resistance.A constant flush had been maintained through the microcatheter.The patient was discharged.It was reported that the devices would be returned for analysis; however, the pulserider was not return.A non-sterile prowler select plus 150/15cm was received coiled inside of a pouch.Inside of it was found stuck a pulserider device.The received microcatheter was inspected and it was found compressed at 1 and 3cm from the distal end.The received microcatheter was inspected under microscope and it was found compressed.An x-ray was performed on the received device and a pulserider device can be observed stuck in the compressed section noted on the received microcatheter.The id from the microcatheter was measured and was found within specification (hub id.021¿ specification:.021¿ minimum, distal id.021¿ specification:.021¿ minimum).The functional analysis cannot be performed since the stuck device cannot be removed from the microcatheter.During the review of the lot 17676317 it was noted that 5 units were rejected due to the defect ¿scrunch¿ and they could be related to the reported complaint.However, the dhr review confirmed that the rejected units were properly segregated and discarded.No other issues were noted that were considered potentially related to the reported complaint.The pulserider device was returned stuck inside a prowler select plus microcatheter.The device could not be removed from the microcatheter (see pi-15094019643528921), so it could not be independently evaluated.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The resistance was confirmed for the prowler and appears to have been related to the compressed section noted on the received device.The cause of the compressed condition was apparently caused by applying excessive force on the catheter, but it could not be conclusively determined.Additionally, inspections are in place that prevents this kind of failure from leaving the facility.Procedural factors and handling process may contribute to the failure as reported.The pulserider was not returned for analysis; therefore, it is not possible confirm if this device contributed to the resistance.There are no current safety signals identified related to the reported events based on review of complaint histories for the devices.Since there was no evidence to suggest the events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: PULSERIDER T, 3MM, 8MM ARCH
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section G): PULSAR VASCULAR; 130 knowles dr suite e; los gatos CA 95032
• Manufacturer Contact: 130 knowles dr suite e; los gatos, CA 95032 ; 6506874920
• MDR Report Key: 7053574
• MDR Text Key: 93092960
• Report Number: 3008680601-2017-00501
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00859030005154
• UDI-Public: (01)00859030005154(17)190531(W3086-07)
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 201-D
• Device Catalogue Number: 201D
• Device Lot Number: W3086-07
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/26/2017
• 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