MAUDE Adverse Event Report: CORDIS NEUROVASCULAR, INC. PROWLER SELECT MICROCATHETERS; CES MICROCATHETERS (KRA)

Catalog Number 606SXXX

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2014

Event Type  malfunction  

Event Description

During the coil embolization procedure assisted with the vrd to treat a middle cerebral artery aneurysm, the enterprise vrd (enc452800/10288544) was inserted through an unspecified y-connector and it got stuck at the hub of the prowler select plus (mc) microcatheter (catalogue and lot unknown).It wasn¿t verified, but according to the physician, at that time, the distal stent markers of the vrd might have been entangled with each other within the microcatheter hub.Therefore, both the vrd and the microcatheter were safely removed as a unit from the patient and the vrd was replaced for a new one (enc452800, lot unknown).Afterwards, the procedure was successfully completed without any further issues.No patient injury/complications were reported.It is unknown if the microcatheter was replaced or not.The complaint product was new and stored per labeling instruction.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all times.Prior to use, no defect (kink, bends etc.) was noted on the product by visual inspection.Also no damages were reported on the device after the event.It is unknown if the microcatheter was re-shaped or not.The complaint product is going to be returned for evaluation.The vessel was not calcified and not tortuous, and access was obtained from right femoral artery.The prowler microcatheter is not going to be return for analysis, and after the enterprise had the event, no additional force or torque was used to further advance the enterprise through the y connector and microcatheter hub.No patient information was provided.No additional information is available and procedural images are not available.

Manufacturer Narrative

The unruptured saccular aneurysm neck was 4.0mm, and the neck to sac ratio was 4.0mm:8.0mm.The parent vessel size diameter proximal was 3.6mm and distally was 3.6mm.No information regarding mrs, inr, pt and ptt was provided.Also the occlusion rate of the aneurysm after the procedure was unknown.Antiplatelet therapy included aspirin 200mg/day and clopidogurel sulfate 75mg/day.Prior to implanting the vrd, unspecified sheath introducer 7fr, (b)(4), 90cm(type unknown)/asahi intecc, prowler select plus(catalogue and lot unknown) were utilized.Other devices utilized during the procedure were, echelon 10(type unknown)/covidien (b)(4).During the procedure, jailed technique was utilized.Regarding the coil embolization, there is no information about the implanted coils.No further information is available and procedural images are not available.Concomitant: 7frsheath introducer, (b)(4), 90cm(type unknown)/asahi intecc, prowler select plus(catalogue and lot unknown) were utilized.Other devices utilized during the procedure were, echelon 10(type unknown)/covidien (b)(4).The product will not be return for analysis, and the lot was not provided.Additional information will be submitted within 30 days of receipt.(b)(4).

Manufacturer Narrative

During the coil embolization procedure assisted with the vrd to treat a middle cerebral artery aneurysm, the enterprise vrd (enc452800/10288544) was inserted through an unspecified y-connector and it got stuck at the hub of the prowler select plus (mc) microcatheter (catalogue and lot unknown).It wasn¿t verified, but according to the physician, at that time, the distal stent markers of the vrd might have been entangled with each other within the microcatheter hub.Therefore, both the vrd and the microcatheter were safely removed as a unit from the patient and the vrd was replaced for a new one (enc452800, lot unknown).Afterwards, the procedure was successfully completed without any further issues.No patient injury/complications were reported.It is unknown if the microcatheter was replaced or not.The complaint product was new and stored per labeling instruction.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all times.Prior to use, no defect (kink, bends etc.) was noted on the product by visual inspection.Also no damages were reported on the device after the event.It is unknown if the microcatheter was re-shaped or not.The complaint products are going to be returned for evaluation.The vessel was not calcified and not tortuous, and access was obtained from right femoral artery.It was noted that the prowler microcatheter was not going to be return for analysis, but part of the microcatheter was received for analysis.After the enterprise had the event, no additional force or torque was used to further advance the enterprise through the y connector and microcatheter hub.No patient information was provided.No additional information is available and procedural images are not available.The unruptured saccular aneurysm neck was 4.0mm, and the neck to sac ratio was 4.0mm:8.0mm.The parent vessel size diameter proximal was 3.6mm and distally was 3.6mm.No information regarding mrs, inr, pt and ptt was provided.Also the occlusion rate of the aneurysm after the procedure was unknown.Antiplatelet therapy included aspirin 200mg/day and clopidogurel sulfate 75mg/day.Prior to implanting the vrd, unspecified sheath introducer 7fr, chikai 14/asahi intecc, okay/goodman, fubuki 7fr, 90cm(type unknown)/asahi intecc, prowler select plus(catalogue and lot unknown) were utilized.Other devices utilized during the procedure were, echelon 10(type unknown)/covidien japan.During the procedure, jailed technique was utilized.Regarding the coil embolization, there is no information about the implanted coils.No further information is available and procedural images are not available.One non sterile enterprise and a section of a unknown prowler microcatheter were received coiled inside of a plastic bag.The introducer tube was not returned for analysis.The delivery wire was received into the section of the microcatheter.The stent was received deployed without any visual damaged.No other anomalies were observed on the received units.The enterprise stent was observed under a microscope and no anomalies were found.The functional analysis could not be performed due the stent was received deployed and the involved microcatheter only received one section and it is necessary that the stent is still inside the introducer tube to perform the functional analysis.The cut section of the microcatheter was inspected under microscope and the condition of the received device was apparently caused for an unknown tool over the device as well as an elongated condition can be observed.The id of hub from the microcatheter was measured and it was found within specification, and the distal id (shaft) cannot be measure due to the damages found on the device (cut section).The microcatheter was flushed using a lab sample syringe (nipro) and after that a 0.018¿ a guide wire lab sample was introduced into the microcatheter and no obstructions were noted on the hub.Lake region medical did review the device history records relative to the manufacturing, inspecting and packaging of lot 10288544.The device history record review also included a review of the certificate of conformance received from specialty coatings systems and nitinol devices and components, along with lake region medical¿s internal receiving inspection records for the stents issued to the complaint lot.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.No dhr could be conducted for the microcatheter, because the lot was not provided.The failure reporter by the costumer as damaged stent markers and luer hub obstruction were not confirmed, because the stent presented no damaged and the luer hub was not obstructed.The failure inability to advance could not be evaluated due the stent was received deployed and only one section of the involved microcatheter was received for analysis.The cause of the events experienced by the costumer could not be conclusively determined.Based on the information and the analysis, procedural/handling factors might have impact on these failures.Note, the returned devices were received damaged, stent deployed, microcatheter cut, etc.That analysis was limited, additionally it was noted that after use the devices were not damaged that indicates that the damages on the units would have occurred after use or during shipping process.The device did not present any obvious indication of manufacturing defect or anomaly that could point to a root cause that would have caused the events as reported.Neither the product analyses nor the dhr review suggests that the failures could be related to the enterprise or mc manufacturing process.Therefore, no corrective actions will be taken at this time.

• Brand Name: PROWLER SELECT MICROCATHETERS
• Type of Device: CES MICROCATHETERS (KRA)
• Manufacturer (Section D): CORDIS NEUROVASCULAR, INC.; 14700 nw 57th court; miami lakes FL 33014
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC (SAN JOSE); 821 fox lane; san jose CA 95131
• Manufacturer Contact: denise singleton ; miami lakes, FL 33014 ; 4084331514
• MDR Report Key: 3666661
• MDR Text Key: 4343315
• Report Number: 1058196-2014-00058
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K021591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 606SXXX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1