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

Catalog Number 606S255X

Device Problem Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/08/2017

Event Type  malfunction  

Manufacturer Narrative

This is initial mdr report being submitted with associated mfr# 3008264254-2017-00039 and 1226348-2017-00049.(b)(4).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 Description

As reported by a healthcare professional, during the procedure there was recapturing difficulty with an enterprise stent.The procedure was coil embolization of an aneurysm at the right internal carotid -c2.The patient was a male whose vessel was heavily torturous and not calcified.The enterprise stent (complaint product1) was attempted to place in the lesion but was misaligned from the planned position.Therefore, the physician tried to recapture the stent in the prowler select plus (complaint product2) for advancement of the catheter to the target position however the edge of the stent (unk distal or proximal) was unable to be stored in the micro catheter.The stent was removed with the catheter as unit.There was no damage detected on the stent and the catheter when removed from the patient; they both were replaced with new products.There was no resistance experienced when the stent passed through the catheter.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.The products are not available for the investigation.No further information is available.

Manufacturer Narrative

This is final mdr report being submitted with associated mfr# 3008264254-2017-00039 and 1226348-2017-00049.Based on the information, the reported event of obstruction of 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
• 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: 6439712
• MDR Text Key: 71051204
• Report Number: 3008264254-2017-00039
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 10886704028888
• UDI-Public: (01)10886704028888(17)190731(10)17551776
• 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,Followup
• Report Date: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2019
• Device Catalogue Number: 606S255X
• Device Lot Number: 17551776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1