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 04/14/2017

Event Type  malfunction  

Manufacturer Narrative

This initial/final mdr will be the only report submitted for mfr report #3008264254-2017-00049.(b)(4).Concomitant product: guidewire (chikai14, asahi intecc), guiding catheter (6fr shuttle sheath, cook inc/ 6fr roadmaster, goodman), balloon catheter (scepter xc).Conclusion: 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.

Event Description

It was reported by a healthcare professional that there was resistance felt between the prowler select plus (606-s255fx/17542524) and the guidewire during a coil embolization procedure at the middle cerebral artery.The prowler select plus (complaint product) was attempted to be used but there was resistance encountered at the proximal portion with the guidewire when it was treated with stent assist.It was unknown how the procedure was completed.The patient¿s vessel was mildly torturous and mildly calcified.Reportedly, the patient¿s information is unknown.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.

• 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: 6544667
• MDR Text Key: 74594956
• Report Number: 3008264254-2017-00049
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• 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
• Date Manufacturer Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1