MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME18 12MM X 40CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	MFR181240
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report the device preliminary photo observations.The embolic coil was noted to being stretched, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter phone number: (b)(4).Manufacturing site name: codman and shurtleff inc., dba depuy synthes products, inc.(fremont).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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of three products involved with the complaint and the associated manufacturer report numbers are 3008114965-2019-01177, 3008114965-2019-01178 and 3008114965-2019-01179.Complaint conclusion: as reported by a healthcare professional, during a coil embolization of an aneurysm at the splenic artery, there was resistance felt between the following coils: 12mm x 40cm micrusframe18 (mfr181240, l14606), 12mm x 40cm micrusframe18 (mfr181240, l14780) and a 10mm x 40cm deltafill18 (dlf181040, l14455) and a prowler select microcatheter (mc) during insertion, inside the microcatheter.The resistance was felt with the same mc.The blood flow was verified by angiography and the complaint coils were not interrupted by the flow.Therefore, the procedure was completed by replaced with another coil and the same mc was used without any problems.The vessel was not excessively tortuous or with acute bends.Adequate and continuous flush was maintained through the catheter.Additional information received confirmed that the coils were unraveled and tangled when removed from the patient.A non-sterile micrusframe18 12mm x 40cm was received inside of a pouch.The hub was inspected, and no damages was noted on it.The dpu was inspected and it was found kinked at 96.5cm and 101cm from the proximal end.The introducer was inspected, and it was found zipped and with no damages on it.The re-sheathing tool was inspected, and it was found without damages.Also, the marker band was found at 75 cm from distal end, and it was found within specification.The v-notch was inspected under microscope and it was found in good normal conditions.The rh was inspected through the introducer under microscope and it was found in good normal conditions.As well as the rh was not heated.The embolic coil was inspected through the introducer and it was found stretched.The functional analysis could not be performed due to the kinked condition noted on the dpu and the stretched condition noted on the embolic coil.A manufacturing record evaluation was performed for the finished device l14606 number, and no non-conformances related to the reported complaint condition were identified.The preliminary photo observation on the micrusframe18 12mm x 40cm (system 1): the dpu was coming out of the introducer, the surface of the microcoil in the sheath was covered with reddish-brown substance, a clear sticky substance was attached to the surface of introducer sheath, reddish-brown substance was attached to surface of microcoil, there is a bent of system at junction of the heating coil and microcoil, dpu is kinked on the proximal side of the radiopaque marker and out of introducer.All the devices were received tangled together, therefore most of the observed damages could be generated due to the product handling.The complaint reported by the customer ¿detachable coil delivery system (dcs)- resistance/friction-during advancement with no loss of cerebral target position¿ was not able to confirm due to the kinked condition noted on the dpu and the stretched condition noted on the embolic coil.The complaint reported by the customer ¿coil- unraveled/stretched-during use¿ was confirm due to the stretched condition noted on the embolic coil.The condition (kinked) noted on the dpu and the stretched condition noted on the embolic coil may have contributed to the failure and appear to have been caused by excessive force and handling being applied to the device however none of those can be conclusively determined.Neither the device history record review nor the product analysis suggest that the reported failure could be related to the manufacturing process of the unit.Based on the information provided, it is possible that clinical and procedural factors, including device manipulation / interaction, vessel characteristics and device selection may have contributed to the reported issues.The instructions for use (ifu) caution that if unusual friction is still noticed during advancement or retraction of the coil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire catheter system and examine for damage.Replace it with a new system.If friction still exists, withdraw and examine the delivery catheter system.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the events were related to a manufacturing or design issue, no corrective actions will be taken at this time.
Event or Problem Description
As reported by a healthcare professional, during a coil embolization of an aneurysm at the splenic artery, there was resistance felt between the following coils: 12mm x 40cm micrusframe18 (mfr181240, l14606), 12mm x 40cm micrusframe18 (mfr181240, l14780) and a 10mm x 40cm deltafill18 (dlf181040, l14455) and a prowler select microcatheter (mc) during insertion, inside the microcatheter.The resistance was felt with the same mc.The blood flow was verified by angiography and the complaint coils were not interrupted by the flow.Therefore, the procedure was completed by replaced with another coil and the same mc was used without any problems.The vessel was not excessively tortuous or with acute bends.Adequate and continuous flush was maintained through the catheter.Preliminary photos from 3 microcoil systems and a prowler select device were received on (b)(4) 2019.Based on the preliminary photo observation, coil (lot# l14455) was stretched and entangled, coil (lot# l14606 was stretched, and coil (lot# l14780 was stretched.Additional information received confirmed that the coils were unraveled and tangled when removed from the patient.

• Brand Name: MICRUSFRAME18 12MM X 40CM
• 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: 9087019
• Report Number: 3008114965-2019-01177
• Device Sequence Number: 19464939
• Product Code: KRD
• UDI-Device Identifier: 10886704078098
• UDI-Public: 10886704078098
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/18/2019

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 Catalogue Number: MFR181240
• Device Lot Number: L14606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1