MAUDE Adverse Event Report: PROWLER SELECT PLUS 150/15CM; CATHETER, CONTINOUS FLUSH

Model Number	606-S252
Medical Device Problem Code	Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Patient age, gender, weight and medical history are unknown.The device has been received for analysis; however, the analysis has not yet been completed.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
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.
Additional 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.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.

• Brand Name: PROWLER SELECT PLUS 150/15CM
• Common Device Name: CATHETER, CONTINOUS FLUSH
• MDR Report Key: 7052693
• Report Number: 3008264254-2017-00501
• Device Sequence Number: 19077058
• Product Code: KRA
• UDI-Device Identifier: 10886704028819
• UDI-Public: (01)10886704028819(17)200331(10)17676317
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K021591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2017

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: 03/31/2020
• Device Model Number: 606-S252
• Device Catalogue Number: 606S252
• Device Lot Number: 17676317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 01/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1