MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ENVOY 6F GUIDING CATHETERS; PERCUTANEOUS CATHETER

Catalog Number	67025690B
Medical Device Problem Code	Split (2537)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion: the device was not returned for analysis.During the review of the lot it was noted that 3 units were rejected due to the defect of delamination in tip and it could be related to the reported complaint.However, the dhr review confirmed that the rejected units were properly segregated and discarded.No other issues were noted that were considered potentially related to the reported complaint.The resistance between the envoy catheter and the cordis sheath and distal tip catheter damage could not be confirmed without product return for analysis.Based on the information provided, it is not possible to determine the root cause of the event; however, the concomitant non-cordis microcatheter may have contributed to the event.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.This is an initial/final mdr report.
Event or Problem Description
As reported by a healthcare professional, an envoy catheter (67025690b/ 17641208) would not advance up the cordis sheath.When it could advance, it was stiff and caused the envoy to split/crack at the tip.No additional information could be provided.

• Brand Name: ENVOY 6F GUIDING CATHETERS
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• MDR Report Key: 6642240
• Report Number: 3008264254-2017-00078
• Device Sequence Number: 13474408
• Product Code: DQY
• UDI-Device Identifier: 10886704031727
• UDI-Public: (01)10886704031727(17)191231(10)17641208
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K000715
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2017

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: 12/31/2019
• Device Catalogue Number: 67025690B
• Device Lot Number: 17641208
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2017
• Initial Report FDA Received Date: 06/14/2017
• Patient Sequence Number: 1