MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG TDL CMPLX FILL COIL 5X10; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CF0510
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of five products involved with the complaint and the associated manufacturer report numbers are 3008114965-2020-00426, 3008114965-2020-00428, 3008114965-2020-00429 and 3008264254-2020-00004.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
As reported by the field, during a coil embolization of a cerebral artery aneurysm, four coils, a 5x10 og tdl cmplx fill (640cf0510, 30132962), a 7x25 og tdl cmplx frame (640cr0725, 30374735), a 4x12 og tdl cmplx fill (640cf0412, 30348520) and a 3.5x9 og cmplx xtrasoft (640cx3509, 30282523) became stuck inside the hub of a prowler select14 microcatheter (product/lot number unknown).The coils ¿never went passed the microcatheter hub.¿ therefore, the microcatheter (mc) never entered the patient¿s intracranial space.The microcatheter was replaced resulting in loss of cerebral target positioning along with the four coils.The procedure was successfully completed with the replacement microcatheter and replacement coils.These coils were not implanted in the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Upon further review, the og tdl cmplx fill coil 5x10 (640cf0510, 30132962) previously reported under this complaint belongs to another complaint.Therefore, the event is being unreported for this medical device.No further reports will be forthcoming.

• Brand Name: OG TDL CMPLX FILL COIL 5X10
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 10573556
• Report Number: 3008114965-2020-00425
• Device Sequence Number: 13773606
• Product Code: KRD
• UDI-Device Identifier: 10886704030294
• UDI-Public: 10886704030294
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2020

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: 08/31/2020
• Device Model Number: 640CF0510
• Device Catalogue Number: 640CF0510
• Device Lot Number: 30132962
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 10/26/2020
• 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 3.5X9; OG TDL CMPLX FILL COIL 4X12; OG TDL CMPLX FRAME COIL 7X25; UNKPROWLERSELECT; OG CMPLX XTRASOFT COIL 3.5X9.; OG TDL CMPLX FILL COIL 4X12.; OG TDL CMPLX FRAME COIL 7X25.; UNKPROWLERSELECT.