MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME18 11MM X 37CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	MFR181137
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Separation Problem (4043)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2019
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)).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by a healthcare professional, during a coil embolization for pulmonary arteriovenous malformation (avm) at the pulmonal artery, a 11mm x 37cm micrusframe18 (mfr181137, l11609) was being used as the first framing coil.However, the concomitant microcatheter was not stable and the complaint coil did not fit in the target lesion.The physician attempted to remove the complaint coil, but there was a resistance felt between the complaint coil and the microcatheter.The coil got split at the hub of the microcatheter.The complaint coil was removed from the patient¿s body.The complaint coil was replaced with another product and the procedure completed safely.The customer states there is no additional information available.The device will not be returned for analysis and therefore, no further investigation can be performed at this time.A manufacturing record evaluation was performed for the finished device l11609 number, and no non-conformances related to the reported complaint condition were identified.With the information available and without the product available for analysis, the reported customer complaint of ¿coil ¿ separated¿ could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.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 event was 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 for pulmonary arteriovenous malformation (avm) at the pulmonal artery, a 11mm x 37cm micrusframe18 (mfr181137, l11609) was being used as the first framing coil.However, the concomitant microcatheter was not stable and the complaint coil did not fit in the target lesion.The physician attempted to remove the complaint coil, but there was a resistance felt between the complaint coil and the microcatheter.The coil got split at the hub of the microcatheter.The complaint coil was removed from the patient¿s body.The complaint coil was replaced with another product and the procedure completed safely.The customer states there is no additional information available.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Section b5: additional information received indicated that the coil prematurely detached at the hub of the microcatheter (mc).No excessive force had been applied to the device.No damage was confirmed prior to use on the device.The device was used and prepped as per the instructions for use (ifu).There was no clinically significant prolongation of the procedure due to the events.The concomitant devices functioned as expected.Section e1: initial reporter phone: (b)(6).Section: h6: device codes ¿ updated to detachment of device or device component based on the new information received.The previous device code, separation problems, reported on the initial mdr is to be removed from the report.Please update accordingly.Updated complaint conclusion: as reported by a healthcare professional, during a coil embolization for pulmonary arteriovenous malformation (avm) at the pulmonal artery, a 11mm x 37cm micrusframe18 (mfr181137, l11609) was being used as the first framing coil.However, the concomitant microcatheter was not stable and the complaint coil did not fit in the target lesion.The physician attempted to remove the complaint coil, but there was a resistance felt between the complaint coil and the microcatheter.The coil got split at the hub of the microcatheter.The complaint coil was removed from the patient¿s body.The complaint coil was replaced with another product and the procedure completed safely.Additional information received indicated that the coil prematurely detached at the hub of the microcatheter (mc).No excessive force had been applied to the device.No damage was confirmed prior to use on the device.The device was used and prepped as per the instructions for use (ifu).There was no clinically significant prolongation of the procedure due to the events.The concomitant devices functioned as expected.The device will not be returned for analysis and therefore, no further investigation can be performed at this time.A manufacturing record evaluation was performed for the finished device l11609 number, and no non-conformances related to the reported complaint condition were identified.With the information available and without the product available for analysis, the reported customer complaint of ¿coil ¿ premature detachment-in microcatheter¿ could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint devices; 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.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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: MICRUSFRAME18 11MM X 37CM
• 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: 8931313
• Report Number: 3008114965-2019-01152
• Device Sequence Number: 11249989
• Product Code: KRD
• UDI-Device Identifier: 10886704078074
• UDI-Public: 10886704078074
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2019

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: 01/31/2021
• Device Catalogue Number: MFR181137
• Device Lot Number: L11609
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 09/26/2019
• 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: MICROCATHETER