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 01/22/2014

Event Type  malfunction  

Event Description

Initially, an unspecified guiding catheter (roadmaster/goodman, 6fr, type unknown) was delivered to internal carotid artery.Then, an unspecified prowler select plus (catalog and lot unknown) was navigated into anterior cerebral artery, and then, the vrd (enc452212/10176365) was successfully placed into the target lesion.No issues noted.The event happened before the coil embolisation.The physician planned to utilize the same microcatheter for the coil embolisation.Although he was inserting the prowler select plus into the lumen of the vrd without removing the delivery wire, the introduction of the microcatheter was failed.As he also experienced severe resistance into the microcatheter, the delivery wire could not be retrieved from the microcatheter.Therefore both the delivery wire of the vrd and the microcatheter were safely removed as a unit from the patient.The coil embolisation was continued using a competitor¿s microcatheter (echelon/covidien (b)(4), type unknown) and coils (details unknown).Afterwards, the procedure was successfully completed without any further issues.No patient injury/complications were reported.

Manufacturer Narrative

No information regarding size of the unruptured saccular aneurysm, vessel size diameter, the medical history, mrs, act, inr, pt, ptt and antiplatelet therapy.The occlusion rate after the procedure also unknown.The devices utilized during the procedure, unspecified sheath introducer 6fr, roadmaster 6fr(type unknown)/goodman, fubuki 4.2fr/asahi intecc, traxcess/terumo, chikai 18/asahi intecc, radifocus gt16/terumo, radifocus gt12/terumo, prowler select plus(catalogue and lot unknown), echelon(size and type unknown)/covidien (b)(4), merit/sheen man.The implanted coils were target/stryker and ed coil/kaneka but no detail information was provided.During the procedure, trans-cell technique was utilized.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.No additional information is available and procedural images are not available.The procedure was coil embolisation assisted with the vrd for a1 segment of right anterior communicating artery aneurysm that was not calcified and heavily tortuous.Access was obtained from right femoral artery.Concomitant medical products and therapy dates: guiding catheter (roadmaster/goodman, 6fr, type unknown); prowler select plus (catalog and lot unknown); competitor¿s microcatheter (echelon/covidien (b)(4), type unknown); coils (details unknown).Sheath introducer 6fr, roadmaster 6fr(type unknown)/goodman, fubuki 4.2fr/asahi intecc, traxcess/terumo, chikai 18/asahi intecc, radifocus gt16/terumo, radifocus gt12/terumo, prowler select plus(catalogue and lot unknown), echelon(size and type unknown)/covidien (b)(4), merit/sheen man.The implanted coils were target/stryker and ed coil/kaneka.

Manufacturer Narrative

After successful deployment of an enterprise vrd across the neck using a prowler select plus, when attempting to access the aneurysm through the stent struts with the enterprise delivery wire and prowler select plus there was severe resistance between the enterprise delivery wire and the delivery wire could not be removed.The devices were safely removed as a unit from the patient.The coil embolization was continued using a competitor¿s microcatheter (echelon/covidien (b)(4), type unknown) and noncodman coils.Afterwards, the procedure was successfully completed without any further issues.No patient injury/complications were reported.The procedure was coil embolization assisted with the vrd for a1 segment of right anterior communicating artery aneurysm that was not calcified and heavily tortuous.No information regarding size of the unruptured saccular aneurysm, vessel size diameter.The device 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.Access was obtained from right femoral artery.Initially, an unspecified guiding catheter (roadmaster/goodman, 6fr, type unknown) was delivered to internal carotid artery.Then, an unspecified prowler select plus (catalog and lot unknown) was navigated into anterior cerebral artery, and then, the vrd (enc452212/10176365) was successfully placed into the target lesion.No issues noted.The event happened before the coil embolization.The physician planned to utilize the same microcatheter for the coil embolization.Although he was inserting the prowler select plus into the lumen of the vrd without removing the delivery wire, the introduction of the microcatheter failed.Severe resistance was experienced into the microcatheter; the delivery wire could not be retrieved from the microcatheter.Therefore both the delivery wire of the vrd and the microcatheter were safely removed as a unit from the patient.A trans-cell technique was utilized for coiling.The occlusion rate after the procedure is unknown.There is no information available regarding the medical history, mrs, act, inr, pt, ptt or antiplatelet therapy.No additional information is available and procedural images are not available.(b)(4).The lot number of the prowler select plus is not known; therefore a device history record review cannot be completed.(b)(4).Lake region medical reviewed the device history records relative to the manufacturing, inspecting and packaging of lot 10176365.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.(b)(4).One non sterile enterprise and prowler select plus microcatheter were received coiled separately inside a plastic bag.The enterprise stent, which as reported remains implanted, and the introducer tube were not received for analysis.The mc hub presented dry blood residuals.The microcatheter was inspected under microscope; it was found dry blood through the body of microcatheter.The id from the microcatheter was measured and was found within specification.The enterprise delivery wire presented no visual damage.No other anomalies were observed on the received units.The involved prowler microcatheter was used to perform a functional test; some resistance/friction was felt with advancement of the enterprise delivery wire and it was stuck at 101.5cm from hub.A lab sample microcatheter was used to perform the functional analysis and the delivery wire was able to go through the mc lab sample without any resistance friction.An attempt to flush the returned prowler microcatheter was made using a lab sample syringe (635-002; however, the flush solution did not come out from the distal end of the microcatheter.A guide wire.018¿ lab sample was then introduced into the microcatheter and it was stuck at 101.5cm from hub.The guide wire was removed from the device.The same a guide wire.018¿ lab sample was introduced tip end into the microcatheter and it was stuck at 53.5cm distal end tip.The guide wire was removed.The microcatheter was cut at 102.5cm from hub and dry blood accumulation was observed within it.After that the guidewire was inserted again and additional force was applied to it and residues of dry blood were expulsed from the cut section.Based on the analysis of the returned devices it appears that the procedural factor of inadequate maintenance of a required continuous flush through the microcatheter as outlined in the enterprise and prowler microcatheter instructions for use may have contributed to the event.Additionally, the instructions for use outlines that after stent deployment, prior to removing the delivery wire, position the microcatheter distal to the stent to maintain access through the stent.It then outlines removal of and discarding of the enterprise delivery wire with placement of an exchange length guidewire through the microcatheter.Usage other than the approved labeling may involve risks not described in the labeling.With review of the returned devices and device history records, there is no indication of any manufacturing issues related to the event with identified possible procedural factors addressed in the labeling.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; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: denise singleton ; miami lakes, FL 33014 ; 4084331514
• MDR Report Key: 3595673
• MDR Text Key: 4064988
• Report Number: 1058196-2014-00030
• 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: 01/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2014
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2014
• 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