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	09/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Information about brand of pushable coil could not be obtained.Conclusion: the device was not returned for analysis.Review of dhr for lot 17379147 concluded there were no issues that were considered potentially related to the reported complaint.The resistance felt within the prowler select plus could not be confirmed without product return for analysis.The root cause of the event could not be determined; however, procedural factors or the unspecified coil may have contributed to the event.There was no evidence to suggest the event was related to a manufacturing issue; therefore, no corrective actions will be taken at this time.This is an initial/final mdr report.
Event or Problem Description
As reported by a healthcare professional, during coil embolization for alteration of blood flow, a pushable coil felt resistance at the hub of a prowler select plus (606s252/17379147), and the unspecified pushable coil could not be advanced.The prowler select plus was replaced with another microcatheter.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 or after the event.The product is not available for investigation.No further information was available.

• 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: 6037991
• Report Number: 3008264254-2016-00070
• Device Sequence Number: 77588
• 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
• Report Date (Section B): 09/27/2016

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): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2016
• Initial Report FDA Received Date: 10/18/2016
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED PUSHABLE COIL