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

Catalog Number	606S255MX
Medical Device Problem Code	Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).It was reported that the device would be returned for analysis; however, the device was not yet returned.Additional information will be provided within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, during coil embolization for the diremption of the internal carotid artery, an enterprise (enf403900/10571456) was delivered into the prowler select plus (606s255mx/16066293), but it got stuck at approximately 15cm from its tip.The enterprise was removed from the microcatheter and the catheter was replaced with another one.The same enterprise was used successfully after replaced the microcatheter.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 or after the event.It was reported that the product will be returned for investigation.The patient¿s vessel was moderately tortuous and moderately calcified.No further information was available.
Additional Manufacturer Narrative
The device was returned for analysis on 12/30/2016.Conclusion: as reported by a healthcare professional, during coil embolization for the diremption of the internal carotid artery, an enterprise (enf403900/10571456) was delivered into the prowler select plus (606s255mx/16066293), but it got stuck at approximately 15 cm from its tip.The enterprise was removed from the microcatheter and the catheter was replaced with another one.The same enterprise was used successfully after replaced the microcatheter.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 or after the event.The product will be returned for investigation.The patient¿s vessel was moderately tortuous and moderately calcified.No further information was available.A non-sterile prowler select plus 5 cm 90 tip was received coiled inside of a plastic bag.The device was inspected and residues of dry blood can be observed along the received device as well as the body was found compressed/kinked at 2, 12 and 62.5 cm from the distal end.The microcatheter was inspected under microscope, and it was found saturated of dry blood and the compressed sections noted on the visual analysis were confirmed.The received device was flushed using a lab sample syringe.A guidewire.018¿ (lab sample) was inserted in the microcatheter and it advance until the distal tip; severe resistance friction was felt when the lab sample guide wire passed through the compressed sections noted on the received microcatheter.The id from the microcatheter was measured, and was found within specification.A review of the manufacturing documentation associated with this lot 16066293 presented no issues during the manufacturing process that can be related to the reported complaint.The inability for the enterprise to be advanced through the prowler select plus microcatheter was not confirmed during the functional test; however, severe resistance friction was felt when advancing a guidewire through the microcatheter.The failure experienced by the customer appears to have been due to the compressed sections found on the received device.The compressed section found on the body of the received microcatheter was apparently caused by applying excessive force on the devices but it could not be conclusively determined.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process, and procedural factors appear to have contributed to this failure.Additionally inspections are in place that prevents this kind of failure from leaving the manufacturing facility.No corrective action 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: 6215893
• Report Number: 3008264254-2016-00098
• Device Sequence Number: 416040
• Product Code: KRA
• UDI-Device Identifier: 10886704028871
• UDI-Public: (01)10886704028871(17)170131(10)16066293
• 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): 12/07/2016

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: 01/31/2017
• Device Catalogue Number: 606S255MX
• Device Lot Number: 16066293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2016
• Supplement Report FDA Received Date: 01/25/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENTERPRISE (ENF403900/10571456)