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

Catalog Number	601251X
Medical Device Problem Code	Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned however evaluation is not yet complete.Results and additional information will be reported within 30 days of when it is available.
Event or Problem Description
The contact from the facility reported that there was strong resistance felt when advancing the coil through the middle portion of the transit microcatheter (601251x/17536303.).The procedure was the pre stent-grafting coil embolization of an aneurysm at the internal iliac artery.The patient¿s information was unknown.The patient¿s vessel level of tortuousness and calcification were unknown.No report of the other device used in the procedure is available.The transit (complaint product) was advanced to the site of embolization.The coil (pushable coil, details unknown) was inserted into the catheter but there was strong resistance felt at the middle portion.The coil was successfully inserted somehow but the physician felt that it may not be safe to use.The catheter was replaced with a competitor microcatheter (details 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 a constant flush was maintained at all times.There was no delay greater than 30 minutes due to the issue.No visible defect/damage was noted on the products prior to (and after) the event.The product will be returned for the investigation.No further information is available.
Additional Manufacturer Narrative
A non-sterile rapidtransit dual marker 150cm microcatheter was received coiled inside of a plastic bag.Residues of dry blood were found in the luer of the hub.No damages were noted on the hub.The microcatheter was inspected and no damages were noted on it.The id from the microcatheter were measured and were found within specification according to document.Hub id: 0.0210¿ specification: 0.021" minimum.Distal id: 0.0210¿ specification: 0.021" minimum.The functional analysis was performed.The received microcatheter was flushed out using a lab sample syringe (nipro), the water came out from the distal end of the device.A 0.018¿ guide wire cordis lab sample was introduced into the microcatheter and it advanced smoothly until the microcatheter¿s distal tip any difficulty.A dcs orbit lab sample was introduced into the microcatheter and it advanced smoothly until the microcatheter distal tip without any difficulty and completely passed through the microcatheter.The review of lot 17536303 revealed no issues that were considered potentially related to the reported complaint.The failure reported by the customer that the catheter experienced resistance/friction in the inner lumen was not confirmed.However, neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process; additionally inspections are in place that prevents these kinds of damages leaving from the facility.Therefore no corrective actions will be taken at this time.

• Brand Name: RAPIDTRANSIT MICROCATHETERS
• Common Device Name: CATHETER, CONTINOUS FLUSH
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• MDR Report Key: 6382983
• Report Number: 3008264254-2017-00025
• Device Sequence Number: 19001838
• Product Code: KRA
• UDI-Device Identifier: 10886704028352
• UDI-Public: (01)10886704028352(17)190630(10)17536303
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K972518
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 601251X
• Device Lot Number: 17536303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2017
• Supplement Report FDA Received Date: 04/04/2017
• Patient Sequence Number: 1