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 12/12/2016

Event Type  malfunction  

Manufacturer Narrative

This is one of one initial mdr report being submitted for this complaint with associated mfr# 3008264254-2016-00094.(b)(4).The product will not be returned for analysis however a device history record review is currently being conducted and the results are not yet available.No conclusion is made at this time.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a health care professional, during pre-evar coil embolization of an aneurysm at the internal iliac artery resistance was experienced with the prowler select plus (606s255fx/17531503) catheter.5-7 coils were inserted successfully through the mc after which coils (type/lot unknown) got stuck in the prowler select plus (complaint product).Therefore the catheter was replaced with another catheter.The procedure was completed without further issues or delay.There was also no patient injury / complication reported.The patient was a (b)(6) female whose vessels were heavily torturous and heavily calcified.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and a constant flush was maintained at all times.No visible defect/damage was noted on the products prior to and after the event.The product is not available for investigation.No further information is available.

Manufacturer Narrative

This is one of one final mdr report being submitted for this complaint with associated mfr# 3008264254-2016-00094.Based on the information, the reported event of resistance experienced with the prowler catheter 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.

• 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: 6205220
• MDR Text Key: 63381422
• Report Number: 3008264254-2016-00094
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 10886704028857
• UDI-Public: (01)10886704028857(17)190630(10)17531503
• 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: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 606S255FX
• Device Lot Number: 17531503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: Y CONNECTOR (OKAY, GOODMAN)ENPOWER
• Patient Age: 83 YR