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 11/18/2016

Event Type  malfunction  

Manufacturer Narrative

The device is expected for return but not yet returned.Additional information will be provided within 30 days.No conclusions are made at this time.

Event Description

The contact from the hospital reported that the enterprise 2 vrd (enc403000/ 10571455) got stuck in a prowler select plus microcatheter (606-s255x/ 17536300).The procedure was to recanalize the basilar artery (compaction 10mm).The patient¿s vessels were moderately tortuous and moderately calcified.A guidewire(chikai, asahi intecc), a guiding catheter (6f fubuki, asahi intecc), a micro catheter (headway, terumo(instead of psp)) and a y connector (goodtec) were also used for this procedure.The procedure intended to place the enterprise (complaint product1) from the left posterior cerebellar artery (pca) to the basilar artery.The pca was very downward, so the approach was difficult.The micro catheter approached the lesion with a straight tip, but as it got to the aneurysm, it could not approach the lesion appropriately.The catheter was removed from the patient¿s body and was reshaped.After that, the catheter could approach the aneurysm.The physician tried to insert the enterprise into the micro catheter but it got stuck at the tip of the catheter just anterior to deploying, and could not be placed in the lesion.Therefore the micro catheter was placed with another one (prowler select plus, 90-degree) and the enterprise was placed.The procedure was successfully completed without further issues.However, due to the event it was delayed for 30 minutes.There was also no patient injury / complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to and after the event.The products will be returned for the investigation.No further information is available.The physician commented that the stuck condition might be caused by reshaping the micro catheter or a thrombus.

Manufacturer Narrative

A non-sterile prowler select plus 150/5cm was received coiled inside of a plastic bag it was inspected and the stent of the enterprise device was found deployed in the distal tip of prowler select plus the received micro catheter was inspected and it was found compressed at 1cm from the distal end.Part of the delivery wire of the enterprise device was found inside of the received micro-catheter.The introducer tube was not received for evaluation.The micro-catheter and the enterprise device stent were inspected under microscope; the micro catheter was found compressed while the enterprise device stent was found without damage.The enterprise device was removed from the micro-catheter and the micro-catheter was flushed using a lab sample syringe ((b)(4).) afterward a lab sample guidewire 0.018¿ was introduced into the microcatheter and severe friction was felt when the guide wire was passed through of the compressed section noted on the received micro catheter.The review of lot 17536300 revealed no issues that were considered potentially related to the reported complaint.The failure reported by the customer that the microcatheter obstructed the stent was not confirmed.The failure experienced by the customer appears was due to the compressed section noted on the received micro catheter.The compressed condition noted on the micro-catheter was apparently caused by applying excessive force on the devices but this could not be conclusively determined.The device did not present any obvious indication of manufacturing defect or anomaly that could contributed to the event as reported.Procedural factors and handling process may contribute to the failure as reported.No corrective action 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: 6175684
• MDR Text Key: 62436058
• Report Number: 3008264254-2016-00091
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 10886704028888
• UDI-Public: (01)10886704028888(17)190630(10)17536300
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 606S255X
• Device Lot Number: 17536300
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2017
• Date Device Manufactured: 07/21/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1