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

Catalog Number 606S255FX

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/24/2017

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

The contact from the facility reported that there was resistance in the prowler select plus catheter (606-s255fx/17542524) when advancing an orbit galaxy coil (details unknown.) the procedure was the coil embolization of an aneurysm for major aortopulmonary collateral artery (mapca.) the patient¿s information was unknown.The patient¿s vessel was moderately torturous and not calcified.No report of the other device used in the procedure is available.The coil (galaxy) was inserted into the prowler select plus (complaint product) but there was resistance felt (it was unknown where part the physician felt the resistance).Therefore, the micro catheter was replaced with another one (same catalog #) and used with the same coil.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 (and after) the event.The product is not available for the investigation.No further information is available.

Manufacturer Narrative

Review of the dhr for lot 17542524 revealed no anomalies that could 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.

• 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: 6333076
• MDR Text Key: 67538308
• Report Number: 3008264254-2017-00018
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 10886704028857
• UDI-Public: (01)10886704028857(17)190731(10)17542524
• 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: consumer,foreign,user facilit
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 606S255FX
• Device Lot Number: 17542524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2017
• Initial Date FDA Received: 02/15/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1