MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC (MEXICO) ENVOY 6F, MPD 100CM; PERCUTANEOUS CATHETER

Catalog Number	67025800
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient date of birth, weight, height, medical history, race, and ethnicity was not reported.(b)(6).The product is available for evaluation and testing; additional information will be submitted within 30 days of receipt.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by a healthcare professional, the middle portion of the 6f envoy mpd 100cm (67025800/17694731) guide catheter was noted to be fractured prior to use in the patient.The unspecified microcatheter could not be inserted due to the fracture.The device was not used in the patient; therefore, no patient complications occurred as a result of the event.The product will be returned for evaluation.No further information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).[complaint conclusion]: as reported by a healthcare professional, the middle portion of the 6f envoy mpd 100cm (67025800/17694731) guiding catheter was noted to be fractured prior to use in the patient.The unspecified microcatheter could not be inserted due to the fracture.The device was not used in the patient; therefore, no patient complications occurred as a result of the event.No further information could be obtained.The envoy guiding catheter was not returned for evaluation.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.With the limited information available and without the product available for analysis, the customer report that the catheter was cracked and obstructed could not be confirmed.Based on the device history record review, there is no indication that the event is related to the manufacturing process of the unit.Catheter damage and obstructed are known potential product failures associated with the use of the device.The instructions for use (ifu) states the following: ¿inspect the catheter upon removal from packaging to verify that it is undamaged.Warning: do not use a catheter that has been damaged in any way.If damage is detected, replace with another envoy guiding catheter that is not damaged.If strong resistance is met during manipulation, discontinue the procedure and determine the cause for the resistance before proceeding.If the cause of the resistance cannot be determined, withdraw the catheter.¿ assignment of root cause for the event remains speculative and inconclusive, based on the minimal information provided and without the return of the complaint product; however, it is possible that procedural and handling factors, including device manipulation, may have contributed to the reported failure.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: ENVOY 6F, MPD 100CM
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC (MEXICO); circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580
• MDR Report Key: 8208392
• Report Number: 1226348-2019-00804
• Device Sequence Number: 1670072
• Product Code: DQY
• UDI-Device Identifier: 10886704031734
• UDI-Public: 10886704031734
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K000715
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 67025800
• Device Lot Number: 17694731
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR