MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC PROWLER SELECT MICROCATHETERS; CES MICROCATHETERS (KRA)

Model Number N/A

Device Problems Kinked (1339); Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2015

Event Type  malfunction  

Event Description

The contact at the facility reported that the prowler select plus microcatheter ((b)(4)) had kink issue at distal tip area and an enterprise stent ((b)(4)) was stuck in the prowler.The physician changed both devices and the procedure was successfully done.At the time of initial contact both products were available for return.

Manufacturer Narrative

The product is expected to be returned for analysis, however it has not been received.Additional information will be submitted within 30 days of receipt.No conclusions are made at this time.This report is related to mfr report reference # 1058196-2015-00133.

Manufacturer Narrative

Review of the dhr for the microcatheter lot# 17116018 did not reveal any anomalies that can be related to the reported complaint.Based on the information, the event could not be confirmed.The product was not returned for analysis; however 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.Therefore, no corrective actions will be taken at this time.

Manufacturer Narrative

A non-sterile prowler select plus 150/5cm was received coiled inside of a plastic bag.The hub was inspected and no damages were noted on it.The body of the device was inspected and a compressed/flattened section was noted on it.The micro-catheter was inspected under microscope and it was found compressed/flattened.The id from the micro-catheter was measured and was found within specification.The micro-catheter was flushed using a lab sample syringe (nipro) and after that a 0.018¿ a guide wire lab sample was introduced into the micro-catheter and it advance smoothly until it was stuck in the compressed/flattened section found on the micro catheter (the lab sample guide wire was removed from the received micro-catheter).After that the micro-catheter was flushed again and a lab sample enterprise was introduced into the micro-catheter and it advance smoothly until it was stuck in the compressed/flattened section found on the micro-catheter.A review of the manufacturing documentation associated with this lot 17076983 presented no issues during the manufacturing process that can be related to the reported complaint.The reported failure that the microcatheter shaft was kinked/bent was confirmed.The reported failure as that the shaft was obstructed was not confirmed during the functional test due to the water can come out from the device from the distal section.The failure experienced by the customer appears was due to the compressed/flattened condition found on the distal section of the received device.The compressed/flattened section found on the device was apparently caused by applying excessive force on the device but it could not be conclusively determined.However this defect could not be related to the manufacturing process and procedural factors appear to have contributed to have this damage.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process.Additionally inspections are in place as to prevent these kinds of failures from leaving the facility.Therefore no corrective action will be taken at this time.

• Brand Name: PROWLER SELECT MICROCATHETERS
• Type of Device: CES MICROCATHETERS (KRA)
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: duane durbin ; 14700 nw 57th court; miami lakes, FL 33014 ; 5088288310
• MDR Report Key: 4862932
• MDR Text Key: 5812759
• Report Number: 1058196-2015-00134
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: KN
• PMA/PMN Number: K021591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: N/A
• Device Catalogue Number: 606S255X
• Device Lot Number: 17076983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2015
• Date Device Manufactured: 08/12/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1