MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME10 2.5MM X 3.3CM

Catalog Number	MFR100253
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2019
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.Procode: krd/hcg.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.Manufacturing site name: codman and shurtleff inc., dba depuy synthes products, inc.(b)(4).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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2019-01084 & 1226348-2019-00943.
Event or Problem Description
As reported by a healthcare professional, during a cerebral embolization to the left anterior communicating artery, a 2.5mm x 3.3cm micrusframe10 coil (mfr100253, l14834), did not advance through the prowler 14 microcatheter (mc) during delivery.The user removed both the coil and the microcatheter and used new prowler and coil.After the change of the devices, the user was able to continue with the embolization with no problem.There was no patient injury reported.There was a 20 minutes procedural delay due to the event.After inspection of the microcatheter, it looks like the distal portion was kinked.No evidence of when if happened and if it is the cause of this situation.The devices were visually inspected for damage prior to use.The devices were used and prepped as per the instructions for use.Adequate flush been maintained through the devices.The devices did not kink or bend at any time prior to the resistance/friction.No excessive force been applied to the devices.The rhv is not a problem, it wasn´t too tight.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Section b5: additional information received indicated that a second micrusframe10 coil (unknown product code/lot) did not advance through a second prowler-14 dual marker microcatheter (606151x, 30051292) during delivery.This is one of four products involved with the complaint and the associated manufacturer report numbers are 3008114965-2019-01084, 1226348-2019-00943, 3008114965-2019-01171 and 1226348-2019-00982.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.As reported by a healthcare professional, during a cerebral embolization to the left anterior communicating artery, a 2.5mm x 3.3cm micrusframe10 coil (mfr100253, l14834), did not advance through the prowler 14 microcatheter (mc) during delivery.The user removed both the coil and the microcatheter and used new prowler and coil.After the change of the devices, the user was able to continue with the embolization with no problem.There was no patient injury reported.There was a 20 minutes procedural delay due to the event.After inspection of the microcatheter, it looks like the distal portion was kinked.No evidence of when it happened and if it is the cause of this situation.The devices were visually inspected for damage prior to use.The devices were used and prepped as per the instructions for use.Adequate flush been maintained through the devices.The devices did not kink or bend at any time prior to the resistance/friction.No excessive force been applied to the devices.The rhv is not a problem, it wasn´t too tight.Additional information received indicated that a second micrusframe10 coil (unknown product code/lot) did not advance through a second prowler-14 dual marker microcatheter (606151x, 30051292) during delivery.A micrusframe10 2.5mm x 3.3cm was received inside a inside of a pouch.The hub was inspected, and no damages were noted on it.The dpu was inspected and it was found in good conditions.The introducer was inspected and it was found zipped and with no damages on it.The re-sheating tool was inspected and it was found in good conditions.Also, the marker band was found at 38cm from hub, and it was found within specification.The v-notch was inspected under microscope and it was found in normal good condition.The rh was inspected under microscope and it was found with no damages on it.Also, it was found not heated.The embolic coil was inspected under microscope and it was found stretched.The functional test could not be performed with the received the prowler-14 dual marker microcatheter due to the multiple kinked/compress conditions noted on it.However, the test was performed with a lab sample prowler select plus.The lab sample prowler select plus was flushed using a lab sample syringe.After that, the unit micrusframe10 2.5mm x 3.3cm was introduced into the lab sample prowler select plus and it could pass through the mc, no resistance/friction was felt.A manufacturing record evaluation was performed for the finished device l14834 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿detachable coil delivery system (dcs) - impeded in microcatheter with loss of cerebral target position¿ was not confirm in the functional test due the received device could pass with no difficulty through the mc.The stretched condition 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 analysis nor the mre suggest that the failure reported by the costumer could be related to the manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the information provided; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size and vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.The ifu states that continuous infusion of an appropriate flush solution is required for optimal performance and indicates that the flush should be verified in the event of resistance/friction during device advancement.Insufficient flush allows blood to back-flow into the microcatheter, which can cause resistance/friction.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.

• Brand Name: MICRUSFRAME10 2.5MM X 3.3CM
• Common Device Name: MICRUSFRAME
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 8773244
• Report Number: 3008114965-2019-01084
• Device Sequence Number: 2043268
• Product Code: KRD
• UDI-Device Identifier: 10886704077770
• UDI-Public: 10886704077770
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2019

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: MFR100253
• Device Lot Number: L14834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 09/11/2019
• 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: PROWLER-14 DUAL MARKER; PROWLER-14 DUAL MARKER; UNKMICRUSFRAME