MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC GUIDE CATHETER; PERCUTANEOUS CATHETER

Catalog Number UNKENVOY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vasoconstriction (2126)

Event Date 03/31/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.  information regarding patient weight, height, medical history, race, and ethnicity was not reported.Cerenovus manufacturer's report numbers: 3008264254-2020-00002 and 3008264254-2020-00003 are related to the same incident.

Event Description

This complaint is from a literature source.As reported in the literature publication entitled ¿optimal guiding catheter length for endovascular coiling of intracranial aneurysms in anterior circulation in era of flourishing distal access system¿.1 patient with anterior circulation aneurysms who underwent aneurysms embolization with guiding catheter envoy experienced significant focal spasm caused by the tip of the envoy catheter.The catheter system needed to be switched from the conventional envoy to the envoy da xb.Purpose: to determine the minimum required guiding catheter length for embolization of various intracranial aneurysms in anterior circulation and to analyze the effect of various patient factors on the required catheter length and potential interaction with its stability.Materials and methods: from december 2016 to march 2017, 90 patients with 93 anterior circulation aneurysms were enrolled.Three types of guiding catheters (envoy, envoy da, and envoy da xb; codman neurovascular, raynham, ma, usa) were used.We measured the in-the-body length of the catheter and checked the catheter tip location in the carotid artery.We analyzed factors affecting the in-the-body length and stability of the guiding catheter system.

• Brand Name: GUIDE CATHETER
• Type of Device: PERCUTANEOUS CATHETER
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; calle circuito interior norte; parque industrial salvarcar; juarez chihuahua ME 32574 ; MX 32574
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10344886
• MDR Text Key: 202691036
• Report Number: 3008264254-2020-00002
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKENVOY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR