MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ENVOY 6F, MPC 90CM; PERCUTANEOUS CATHETER

Catalog Number	67025690
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Product was received and is pending evaluation.The manufacturer will submit a supplemental report once evaluation is completed.Missing information from this report is identified as blank; 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 or Problem Description
The healthcare professional reported that during the diagnostic angiogram procedure, the envoy® guiding catheter, 6f, 90 cm, mpc leaked diagnostic contrast.The reported leak was noted when the catheter was being flushed.The leak was discovered prior to the catheter being inserted into the patient.It was reported that the location of the leak was at the weld junction between the proximal blue and distal yellow polymer segment of the catheter.The envoy guiding catheter did not appear damaged prior to the leak being noticed; no excessive force was applied.Another envoy guiding catheter was used to continue and complete the procedure.There was no report of procedural delay, no report of patient injury or adverse event associated with the reported issue.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigation finding of the returned device.[conclusion]: the healthcare professional reported that during the diagnostic angiogram procedure, the 6f, 90 cm, mpc envoy® guiding catheter (67025690 / 30057700) leaked diagnostic contrast.The reported leak was noted when the catheter was being flushed.The leak was discovered prior to the catheter being inserted into the patient.It was reported that the location of the leak was at the weld junction between the proximal blue and distal yellow polymer segment of the catheter.The envoy guiding catheter did not appear damaged prior to the leak being noticed; no excessive force was applied.Another envoy guiding catheter was used to continue and complete the procedure.There was no report of procedural delay, no report of patient injury or adverse event associated with the reported issue.The envoy® guiding catheter was returned for evaluation testing.The investigation finding is documented below.Investigation summary: the envoy® guiding catheter was received coiled and contained in a pouch.The device was inspected; no damage was noted on the device.The functional analysis was performed.The envoy® guiding catheter was flushed with water using the lab sample syringe (635-002).Water was observed leaking out of the distal fusion between the catheter body shaft and the distal tip.The reported issue was confirmed with the functional analysis finding.A review of manufacturing documentation associated with this lot (30057700) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The reported issue in the complaint that envoy® guiding catheter leaked diagnostic contrast during the procedure was confirmed during the functional test performed on the returned device.The issue will be tracked and monitored by the product engineering team.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The issue will be tracked and monitored by the product engineering team.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.The product engineering team has opened a nonconformance report to track and monitor this issue of leak as related to the 6f, 90 cm, mpc envoy® guiding catheter (67025690).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.

• Brand Name: ENVOY 6F, MPC 90CM
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• MDR Report Key: 8020157
• Report Number: 1226348-2018-00752
• Device Sequence Number: 1353146
• Product Code: DQY
• UDI-Device Identifier: 10886704031710
• UDI-Public: 10886704031710
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K093184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2018

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: 03/31/2021
• Device Catalogue Number: 67025690
• Device Lot Number: 30057700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Initial Date Received by Manufacturer: 10/09/2018
• Supplement Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1