MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC PROWLER SELECT MICROCATHETERS; CATHETER, CONTINOUS FLUSH

Catalog Number 606S255X

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2016

Event Type  malfunction  

Manufacturer Narrative

This is two of two initial mdr report being submitted for this complaint with associated mfr# 3008264254-2016-00062 and 1226348-2016-00146.(b)(4).Concomitant products: microvention 8mm complex coil; pipeline flow diverter; prowler select plus microcatheter 5cm tip.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The product has been forwarded to codman for evaluation and testing, however the analysis has not been completed.Additional information will be submitted within 30 days of receipt.No conclusions are made at this time.

Event Description

As reported by a health care professional, during coiling of a 1.5 mm basilar tip aneurysm physician attempted to place one enterprise2 (enf403012/10582428) stent in the left posterior communicating artery.Physician positioned prowler select plus (606s255x/17435284) with 5cm tip into position and attempted to deploy the stent.Extreme resistance was encountered when attempting to push the stent out the distal end of the microcatheter.The entire system was removed and a new prowler select plus with 5cm tip and new enterprise 2 were placed.The second stent tracked and deployed without any issues or resistance.An adequate continuous flush was maintained through the catheter and there were no damages noted on the catheter or the stent prior to use.There were no serious injuries or medical interventions due to the reported event.The patient condition is reported to be stable and recovering, the patient's vessels were reported to be of medium tortuosity.Physician suspected either a kink in the microcatheter or issue with the stent.Both the enterprise 2 stent and the prowler select plus catheter is available for analysis.

Manufacturer Narrative

This is two of two final mdr report being submitted for this complaint with associated mfr# 3008264254-2016-00062 and 1226348-2016-00146.A non-sterile prowler select plus 150/5cm microcatheter was received coiled in the original packaging pouch inside of a plastic bag.No damages were noted on the hub.The microcatheter was inspected and was found compressed section at 4.5 cm from the distal end tip.Some waves were noted on the device; however these appear to have occurred during the handling of the unit when it was returned for evaluation.The microcatheter was inspected under vision system; compressed section was noted on the body.The id from the microcatheter was measured and was found to be within specification.Hub id: 0.0215¿, specification: 0.021" minimum.Distal id 0.021¿¿ specification: 0.021" minimum.The functional analysis was performed; the received microcatheter was flushed out using a lab sample syringe (nipro) and the water came out from the distal end of the device.A 0.018¿ guide wire cordis lab sample was introduced into the microcatheter and it advance smoothly until the microcatheter¿s distal tip; resistance was felt when the wire passed through the compressed section of the microcatheter.The received enterprise under investigation (b)(4) could not be introduced into the microcatheter as it was saturated with residues of dry blood.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.This defect was reviewed against fmea and no issues were noted that were considered potentially related to the reported complaint.The reported failure of the microcatheter being obstructed was not confirmed during the functional analysis.The cause of the failure experienced by the customer appears to be due to the compressed section found on the device, the cause of these defects could not be conclusively determined.However, neither the analysis nor the dhr suggest that the failure reported could relate to the manufacturing process.Therefore no corrective actions will be taken at this time.

• Brand Name: PROWLER SELECT MICROCATHETERS
• Type of Device: CATHETER, CONTINOUS FLUSH
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: karen anigbo ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 5088288374
• MDR Report Key: 5999469
• MDR Text Key: 56453006
• Report Number: 3008264254-2016-00062
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 10886704028888
• UDI-Public: (01)10886704028888(17)190228(10)17435284
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021591
• 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
• Report Date: 09/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 606S255X
• Device Lot Number: 17435284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1