MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC PROWLER SEL PLUS 150/5CM 45TIP; CATHETER, CONTINOUS FLUSH

Catalog Number 606S255FX

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information regarding patient age, gender, weight, race, ethnicity, and medical history were not provided.This information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a health care professional, during a coil embolization to the internal carotid artery (ica), when the user was introducing the pulserider (201d,w3086-18), into the prowler select microcatheter (606s255fx, 17751958), the pulserider could not advance through the sheath while was inserted into the microcatheter hub.The sales representative advised the user to retract the pulserider further back into the protective sheath and cutting the protective sheath at a 45° angle to allow it to advance into the micro catheter hub.At this point the issue was resolved.There was about an hour of procedural delay due to the troubleshooting to advance the device.However, the physician was unable to navigate the tortious anatomy to appropriately place, so the device was removed and patient was taken to surgery.The physician has reported that this was not because of device failure but because of the patient¿s anatomy.The product will be returned for analysis.The physician flush the device as directed per instructions for use (ifu).After inspecting the device and sheath, it was noticed that the introducer sheath was thicker on one side keeping the sheath from centering itself into the microcatheter.The user noted that resistance/friction occurred due to the introducer sheath being either too thin or too thick to center itself into the hub of the micro catheter.Continuous flush was maintained through all catheters during the procedure.The device was appropriately sized to the vessel.The user inspected the pulserider to make sure that it had not been damaged during the prior attempts to advance and it was intact and looked great as did the microcatheter.Additional information indicated that there was no kink during pre/post procedure observation.Or when the device was being packaged to be return.

Manufacturer Narrative

Product complaint # (b)(4).Complaint conclusion: as reported by a health care professional, during a coil embolization of the internal carotid artery (ica), when the user was introducing the pulserider (201d,w3086-18), into the prowler select microcatheter (606s255fx, 17751958), the pulserider could not advance through the sheath while it was inserted into the microcatheter hub.The sales representative advised the user to retract the pulserider further back into the protective sheath and cutting the protective sheath at a 45° angle to allow it to advance into the micro catheter hub.At this point the issue was resolved.There was about an hour of procedural delay due to the troubleshooting to advance the device.However, the physician was unable to navigate the tortious anatomy to appropriately place, so the device was removed and patient was taken to surgery.The physician has reported that this was not because of device failure but because of the patient¿s anatomy.The product will be returned for analysis.The physician flush the device as directed per instructions for use (ifu).After inspecting the device and sheath, it was noticed that the introducer sheath was thicker on one side keeping the sheath from centering itself into the microcatheter.The user noted that resistance/friction occurred due to the introducer sheath being either too thin or too thick to center itself into the hub of the micro catheter.Continuous flush was maintained through all catheters during the procedure.The device was appropriately sized to the vessel.The user inspected the pulserider to make sure that it had not been damaged during the prior attempts to advance and it was intact and looked great as did the microcatheter.A non-sterile prowler sel plus 150/5cm 45tip was received coiled inside of a pouch.The received device was inspected and no damages were noted on it.The id from the micro-catheter was measured and was found within specification.The received device was flushed and after that a guide wire.018¿¿ lab sample was introduced into the received mc from the hub and the lab sample guide wire was passing through of the mc without any difficulty.The dhr review of the manufacturing documentation associated with this lot 17751958 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The failures reported by the costumer as ¿cbs ¿ obstructed-in patient with loss of mc cerebral target position¿ was not confirmed during the functional test.Procedural factors and handling process may contribute to the failure as reported.The ifu warns to never advance or withdraw an intraluminal device against resistance.Movement or force of catheter or guide wire against resistance could dislodge a clot, perforate a vessel wall, or severely damage the catheter and/or guide wire.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: PROWLER SEL PLUS 150/5CM 45TIP
• Type of Device: CATHETER, CONTINOUS FLUSH
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham 02767
• MDR Report Key: 7267285
• MDR Text Key: 100254991
• Report Number: 3008264254-2018-00511
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 10886704028857
• UDI-Public: 10886704028857
• Combination Product (y/n): N
• PMA/PMN Number: K021591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 606S255FX
• Device Lot Number: 17751958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Date Manufacturer Received: 03/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention