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

Catalog Number 606S255X

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 08/04/2016

Event Type  Injury  

Manufacturer Narrative

This is one of two initial mdr report being submitted for this complaint with associated mfr number 3008264254-2016-00053.(b)(4).The product is expected to be returned for analysis, however it has not been received.Additional information will be submitted within 30 days of receipt.No conclusions are made at this time.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.

Event Description

As reported by a health care professional, during a thrombectomy procedure at the middle cerebral artery the physician wanted to make a second pass with a competitor's thrombectomy device.The physician could no longer push the competitor's device through the prowler select plus (606s255x/17330342) microcatheter; the device got stuck half way in the catheter.It was not possible to push the device.The same problem occurred with the second prowler select plus (606s255x/17330342) catheter.The procedure was completed with a new prowler select plus catheter (lot unknown) and the same thrombectomy device passed through it without any issues; however the surgery was delayed by 35 minutes.There were no damages or kinks noted on the two complaint prowler catheter and no damages were noted on the competitor's thrombectomy device.An adequate continuous flush was maintained through the catheter at all times.There were no adverse events reported.Patient was a (b)(6) male; whose vessels were not very tortuous.It was initially reported that both the complaint prowler select plus catheters are available for return.

Manufacturer Narrative

This is one of two final mdr report being submitted for this complaint with associated mfr number 3008264254-2016-00052 and 3008264254-2016-00053.Device returned on 06sep2016.A non-sterile prowler select plus 150/5cm was received coiled inside of a plastic bag.The received device was inspected and was found to be kinked at 5 and 80cm from the proximal end of hub.The received micro catheter was inspected under the microscope and was found to be kinked.The id and od of the micro-catheter were measured and were found to be within specifications.Hub id 0.021¿ specification:.021" minimum; distal id 0.021¿ specification:.021" minimum.The received mc was flushing using a lab sample syringe.After which a guide wire.018¿¿ lab sample was introduced into the received mc and it advanced until it was stuck at 13cm from the proximal end, the guide wire was removed.The microcatheter was then cut at 14cm from the proximal end and the lab sample guide wire was inserted again; resistance friction was felt and additional force was applied on the device and then residues of dry blood and dry saline solution were exposed.A review of the manufacturing documentation associated with this lot 17330342 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The reported failure of obstruction of microcatheter was confirmed during the functional test.The failure experienced by the customer appears to be due to the kinked condition and residues of dry blood and dry saline solution found in the micro catheter.The kinked condition noted on the micro catheter was apparently caused by excessive force applied on the device but it could not be conclusively determined.Since there was no evidence of a manufacturing issue related to the event, no corrective action will be taken at this time.(b)(4).

• 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: 5910373
• MDR Text Key: 53352720
• Report Number: 3008264254-2016-00052
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 606S255X
• Device Lot Number: 17330342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 70