MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC UNKPROWLERSELECT; PROWLER SELECT

Catalog Number UNKPROWLERSELECT

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Information regarding patient age, gender, weight, race, ethnicity, and medical history were not provided.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, after multiple attempts to ¿land¿ the pulserider (311d, w3092-01) intrasaccular, the decision was made to remove the pulserider and the.021 prowler select plus together.Somehow, the prowler select plus ¿wrapped¿ around the medtronic phenom.017 microcatheter.Both microcatheters were removed from patient.Both pulserider and the micro catheters were replaced with new devices.The procedure was successfully completed.The surgery was not delayed due to the event.

Manufacturer Narrative

(b)(4).Complaint conclusion: as reported by a health care professional, after multiple attempts to ¿land¿ the pulserider ((b)(4)) intrasaccular, the decision was made to remove the pulserider and the.021 prowler select plus together.Somehow, the prowler select plus ¿wrapped¿ around the medtronic phenom.017 microcatheter.Both microcatheters were removed from patient.Both pulserider and the micro catheters were replaced with new devices.The procedure was successfully completed.The surgery was not delayed due to the event.Multiple attempts to gather additional information have been made and have been unsuccessful.(b)(4) a non-sterile micro-catheter prowler select plus 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.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 cannot be performed due to the lot number was not provided.The failures reported by the costumer as ¿catheter (body/shaft)¿ obstructed¿ was not confirmed during the functional test.Based on the limited information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the event.However, procedural factors and handling process may contribute to the failure as reported.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: UNKPROWLERSELECT
• Type of Device: PROWLER SELECT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham 02767
• MDR Report Key: 7266457
• MDR Text Key: 99911856
• Report Number: 1226348-2018-00520
• Device Sequence Number: 1
• Product Code: KRA
• 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: 01/19/2018

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 Catalogue Number: UNKPROWLERSELECT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• Date Manufacturer Received: 03/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention