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 Intracranial Hemorrhage (1891)

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Date of event: the date of the event/study is not known.The product catalog and lot numbers are not available / not reported.The unique identifier (udi) and expiration date of the device is not known.Information such as initial reporter facility name, address, city, state, name, phone, and email address are not available / reported.The device manufacture date is not known as the product lot number of the device is not available / not reported.[conclusion]: the following complications were reported through the (b)(6) report source on behalf of the (b)(6), via study number (b)(4) that aligned to the cerenovus product envoy guiding catheter.It was reported that seventy-nine (79) patients underwent an endovascular treatment procedure for an unruptured intracranial aneurysm with the envoy guiding catheter device (unknown product code / unknown lot #); the patients experienced intracranial bleeding at the time of the index procedure and not present on admission.Based on complaint information, the devices were not available to be returned for analyses.The device lot numbers were not available.The manufacturing documentation review could not be performed without the lot numbers.Product analyses cannot be conducted as the products were not returned for analyses.In addition, there was no report of malfunction associated with the devices.As such, the investigation will be closed.With extremely limited information available, the relationship between device and the adverse event cannot be determined.Since these conditions can cause permanent damage/death or may require medical intervention to prevent permanent damage/death, these events are mdr reportable.There was no information on patient medical history, and no information on the device and its performance during use in the study procedure and no information related to concomitant devices used during the procedure.The device catalog and lot numbers are not known; therefore, the determination of possible device-related causes cannot be determined through device analysis or through device history record review.The exact cause of the event could not be conclusively determined.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.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.This is one of five products involved with the reported complaint.The associated manufacturer report numbers are: 1226348-2021-00017, 1226348-2021-00018, 1226348-2021-00019, 1226348-2021-00020, and 1226348-2021-00021.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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

The following complications were reported through the (b)(6) report source on behalf of the (b)(6), via study number (b)(4)that aligned to the cerenovus product envoy guiding catheter.It was reported that seventy-nine (79) patients underwent an endovascular treatment procedure for an unruptured intracranial aneurysm with the envoy guiding catheter device (unknown product code / unknown lot #); the patients experienced intracranial bleeding at the time of the index procedure and not present on admission.

• Brand Name: GUIDE CATHETER
• Type of Device: PERCUTANEOUS CATHETER
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• 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 dr; irvine, CA 92618 ; 949789-868
• MDR Report Key: 11634535
• MDR Text Key: 254126956
• Report Number: 1226348-2021-00021
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K000715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• 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
• Date Manufacturer Received: 03/31/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening