MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC PROWLER SELECT PLUS 150/5CM; CATHETER, CONTINUOUS FLUSH

Model Number 606-S255X

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.(b)(6).The device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.Device manufacturer date - not available at this time.This is one of two products involved with the complaint and the associated manufacturer report numbers are 1226348-2019-01034.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

As reported by a healthcare professional, during a stent-coil embolization, a 4.5mmd 37mml enterprise stent delivery system (enc453700, 11175281) could not advance in the 150/5cm prowler select plus microcatheter (606s255x, 30254238).The physician withdrew the stent and microcatheter (mc) outside of the patient together.The cerebral target position was lost.There was no patient injury reported.The procedure was completed with new products.

Manufacturer Narrative

Product complaint # pc-(b)(4).Updated sections on this report: section b5, g4, g7, h2, and h10.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Section b5: additional information received indicated that other devices were successfully used with the prowler select prior to the encountered issue.No additional intervention was needed to remove the devices from the patient.A ¿little bit force¿ was used through the catheter pull back.Adequate flush was been maintained through the devices.The devices were not inspected prior to use.There was no significant clinical prolongation of the procedure due to the event.

• Brand Name: PROWLER SELECT PLUS 150/5CM
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 9489784
• MDR Text Key: 206955336
• Report Number: 1226348-2019-01035
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 10886704028888
• UDI-Public: 10886704028888
• Combination Product (y/n): N
• PMA/PMN Number: K021591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 606-S255X
• Device Catalogue Number: 606S255X
• Device Lot Number: 30254238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 12/19/2019; 01/14/2020
• Supplement Dates FDA Received: 01/07/2020; 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EU ENT4.5MMD 37MML WNO DSTL TP