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

Catalog Number 606S255FX

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2017

Event Type  malfunction  

Manufacturer Narrative

This is initial mdr report being submitted with associated mfr# 3008264254-2017-00099 and 3008264254-2017-00100.(b)(4).(b)(6).The product is available 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 healthcare professional, during the procedure resistance was experienced when using a trufill coil (633370x/17116021) and a prowler select plus catheter (606s255fx/17625506).The procedure was pre-endovascular aneurysm repair coil embolization of an aneurysm at the left internal iliac artery.The patient was (b)(6) male whose vessel was heavily torturous and heavily calcified.Reportedly at the beginning of the procedure, the trufill (complaint product1) was used but there was unusual resistance and it got stuck in the prowler select plus (complaint product2).Therefore, the micro catheter was replaced with another one.The remaining procedure was completed with trufill (unknown lot).The procedure was successfully completed without further issues or delay.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 the event.No unintended detachment was observed in the vessel or in the microcatheter.Only product (prowler select plus) will be returned for investigation.No further information is available.The trufill has already been disposed and not available for the investigation.

Manufacturer Narrative

This is final mdr report being submitted with associated mfr# 3008264254-2017-00100.A non-sterile prowler sel plus 150/5cm 45tip was received coiled inside a plastic bag.The received device was inspected and residues of dry blood can be observed along the received device.The received micro catheter was inspected under the microscope and residues of dry blood can be observed on it.The id of the micro-catheter was measured and was found to be within specification.Hub id.021¿, specification:.021¿ minimum.Distal id.021¿, specification:.021¿ minimum.Flushing of the received mc was attempted however the catheter would not flush; after that, a sample guide wire.018¿¿ was introduced into the received mc.It advanced until it was stuck at 48cm from the proximal end, the guide wire was removed.After that the mc was cut at 49cm from the proximal end and the lab sample guide wire was inserted again; resistance friction was felt and additional force was applied on the device and then residues of dry blood were ejected from the cut section.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 failure reported by the customer as ¿cbs ¿ obstructed¿ was confirmed during the functional test.The failure experienced appears to be due to residues of dry blood found in the micro catheter.Process and procedural factors appear to have contributed to this failure, no corrective action will be taken at this time.There is no current safety signal identified related to the reported event(s) based on review(s) of complaint history(ies) for the device.

• 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: 6673526
• MDR Text Key: 78594694
• Report Number: 3008264254-2017-00099
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 10886704028857
• UDI-Public: (01)10886704028857(17)191130(10)17625506
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 606S255FX
• Device Lot Number: 17625506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1