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

Catalog Number	606S252
Medical Device Problem Code	Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is initial report being submitted for this complaint with associated mfr# 3008264254-2017-00001.(b)(4).Concomitant products: guide wire (chikai, asahi intecc); guiding catheter (6f fubuki, asahi intecc); micro catheter (psp); y connector (goodtec, goodman).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 or Problem Description
As reported by a healthcare professional, during the procedure resistance was experienced with prowler select plus (606s252/17379147) catheter.The procedure was for treatment of acute ischemic stroke at the internal carotid artery.The patient was male whose vessels were moderately torturous and moderately calcified.The lesion was the m2.After crossing with the complaint prowler select plus, a revive was delivered.However there was resistance felt with the complaint prowler select plus.Therefore it was replaced with a new micro catheter (non-codman).The physician reported that the same incident occurred twice in a row, and seemed to be getting doubtful with prowler select plus.The procedure was successfully completed without further issues.However, due to the event it was delayed for 30 minutes.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.No unintended detachment was observed in the vessel or in the micro catheter.The product is not available for the investigation.No further information is available.
Additional Manufacturer Narrative
This is final report being submitted for this complaint with associated mfr# 3008264254-2017-00001.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
• Common Device Name: CATHETER, CONTINOUS FLUSH
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• MDR Report Key: 6248937
• Report Number: 3008264254-2017-00001
• Device Sequence Number: 862324
• Product Code: KRA
• UDI-Device Identifier: 10886704028819
• UDI-Public: (01)10886704028819(17)181031(10)17379147
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 606S252
• Device Lot Number: 17379147
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2017
• Supplement Report FDA Received Date: 01/27/2017
• Patient Sequence Number: 1