MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENVOY DA, 6F, 105CM, MPD; PERCUTANEOUS CATHETER

Model Number	671-258-05D
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.The company is seeking this information through the event investigation.A supplemental report will be submitted 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 tip of a 6f, 105cm envoy da guide catheter (67125805d, e12018) was cracked.There was no patient injury reported.No additional information is available at this time.
Additional Manufacturer Narrative
Product complaint #: (b)(4).The purpose of this mdr is to include the additional event information received on 4/26/2020.The additional event information resulted in a change in the reportability of this complaint.Therefore, it has been deemed not reportable.No further reports will be forthcoming.Section b5: additional information received indicated that there was a kinked and not a crack on the tip.One non-sterile envoy da, 6f, 105cm, mpd unit was received inside of a pouch.The received device was visually inspected and the distal tip was found compressed.No other damages were observed on the device.A manufacturing record evaluation was performed for the finished device e12018 number, and no non-conformances related to the reported complaint condition were identified.

• Brand Name: ENVOY DA, 6F, 105CM, MPD
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 9928105
• Report Number: 3008114965-2020-00089
• Device Sequence Number: 10938114
• Product Code: DQY
• UDI-Device Identifier: 10878528000676
• UDI-Public: 10878528000676
• Combination Product (Y/N): N
• PMA/510(K) Number: K000715
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2020

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: 12/31/2021
• Device Model Number: 671-258-05D
• Device Catalogue Number: 67125805D
• Device Lot Number: E12018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2020
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 05/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1