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 10/09/2016

Event Type  malfunction  

Manufacturer Narrative

This is two of two initial mdr report being submitted for this complaint with associated mfr# 3008264254-2016-00077 and 1226348-2016-00158.(b)(4).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 healthcare professional, during a stent assisted coil embolization procedure on (b)(6) 2016 an enterprise stent (enc452800/10560703) could not be advanced through a prowler select plus microcatheter (606s255x/17330341).The resistance was experienced when the stent was being advanced through the catheter shaft.The stent was withdrawn with the microcatheter and new products were used to complete the procedure.No intra or post procedural complications or surgical delays related to device or reported event were reported.There was no report on patient injury.There were no damages noted on the complaint stent and the catheter prior to use or upon removal.It was verified that the introducer was fully seated & secured in the hub.The device did not move out forward out of the introducer during insertion into the catheter hub.An adequate continuous flush was maintained through the catheter.It was verified that the introducer was fully seated & secured in the hub.It was initially reported that the complaint products are available for analysis.

Manufacturer Narrative

This is two of two final mdr report being submitted for this complaint with associated mfr# 3008264254-2016-00077 and 1226348-2016-00158.A non-sterile enterprise device ((b)(4)) was received inside of a micro-catheter ((b)(4)).It was noted that a tape was attached to the introducer tube and the stent was not inside the introducer.No other damages were noted on the enterprise device while the micro-catheter was found compressed at 1, 4, 5, 14 and 15.5cm from the distal end.The stent was removed from the micro catheter and it and the received micro catheter were inspected under microscope; the stent was found without damage while the micro catheter was found compressed.The received micro-catheter was flushed using a lab sample syringe (635-002), after which a guide wire.018¿ lab sample was introduced into the micro-catheter; slight friction was felt when the guide wire was passed through of the compressed sections noted on the received device.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 reported failure of the prowler catheter being obstructed was not confirmed during the functional test, the failure experienced appears to be due to the compressed sections noted on the received micro catheter.The compressed sections noted on the received micro catheter were apparently caused by excessive forces applied on the device but it could not be conclusively determined.However this defect could not be related to the manufacturing process.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: 6078954
• MDR Text Key: 59226681
• Report Number: 3008264254-2016-00077
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 10886704028888
• UDI-Public: (01)10886704028888(17)180831(10)17330341
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 10/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 606S255X
• Device Lot Number: 17330341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1