MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENVOY DA XB, 6F, 95 CM, MPD; PERCUTANEOUS CATHETER

Model Number	671-258-95DB
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/30/2020
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.The lot number was not provided at the time of report.The product is not available for evaluation and testing.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, during a coil embolization, the tip of a 6f, 95cm envoy da xb catheter (67125895db, lot unknown) 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.The lot number is not known; therefore a device history record review cannot be completed.

• Brand Name: ENVOY DA XB, 6F, 95 CM, 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: 9967435
• Report Number: 3008114965-2020-00106
• Device Sequence Number: 4597352
• Product Code: DQY
• UDI-Device Identifier: 10886704075110
• UDI-Public: 10886704075110
• 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,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2020

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 Model Number: 671-258-95DB
• Device Catalogue Number: 67125895DB
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 04/26/2020
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OG CMPLX XTRASOFT COIL 3X6