MAUDE Adverse Event Report: REFER TO SECTION H10 MC 32, 150 CM, FLOWDIV, XXB; CATHETER, PERCUTANEOUS

Catalog Number	MC32150ZBX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional information received on 24-jan-2019 indicated that the event resulted in a loss of cerebral target position.Based on this information, the event now meets the criteria for mdr reporting.Information regarding patient age/date of birth, gender, weight, height, medical history, race, and ethnicity was not reported.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)).(b)(6).Initial reporter occupation: lead interventional neuroradiologist.[complaint conclusion]: as reported by a healthcare professional, during a flow diversion of a large cavernous fusiform recurrent anterior choroidal artery (acha) aneurysm, the yoga 32 xxb (mc32150zbx/c42462) microcatheter was tracked to the target aneurysm, but the 4.0x27mm bravo (fdc4027/11020352) flow diverter could not be advanced through the body of the microcatheter.The physician reportedly exerted a lot of force in an attempt to deliver the bravo through the yoga, and even utilized a torque device, but the bravo would not exit the microcatheter.The bravo and yoga were subsequently retrieved as a system from the patient, resulting in a loss of cerebral target position.Upon removal of the devices, the wire of the braid at the proximal end of the bravo was noted to have frayed.It was stated that ¿extensive forces were applied to the device which created friction and fraying on delivery wire (outside the body)¿.The bravo device was still on the delivery wire when removed from the patient.The devices were replaced, and the procedure was completed successfully.The bravo was replaced with a smaller bravo.No patient complications occurred as a result of the event.The five-minute delay in procedure was not considered clinically significant.The vessel was extremely tortuous with an acute bend just proximal to the aneurysm location.No visible product damage was noted prior to the event.The catheter did not appear damaged upon removal.There was no difficulty during introduction of the catheter over the guidewire prior to the attempted use of the bravo device.The user verified that the introducer was fully seated and secured in the hub during advancement.An adequate and continuous flush was maintained through the catheter.No further information could be obtained.The yoga 32xxb microcatheter was returned with the bravo fdc4027 in the same package.The mc 32 is the recommended size for a 4.0 x 27 mm bravo device per the instructions for use (ifu).Upon receipt of the complaint device, visual inspection was conducted.No kinks or external damage was seen along the length of the microcatheter.The bravo mesh implant was seen separated from its delivery wire and in the shaft/hub of the yoga microcatheter.There were no other visual anomalies observed during the visual inspection.After the visual inspection was conducted, the bravo implant was carefully removed from the microcatheter using tweezers.A lab sample sv-5 guidewire was completely advanced through the yoga microcatheter with no resistance felt.Functional testing with the bravo device could not be performed due to the detached condition of the bravo.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The customer report of catheter obstructed was confirmed.The mesh implant of the bravo device was found stuck inside the hub/proximal shaft of the returned microcatheter; however, the implant was removed, and a lab sv-5 guidewire was successfully advanced through the catheter with no resistance.Functional testing could not be performed with the bravo device to determine potential root causes of the event due to the condition of the returned bravo.The exact circumstances surrounding the observed separation from the delivery wire cannot be determined based on the condition of the returned device; however, additional information received indicated that the bravo implant appeared to be on the delivery wire when removed from the patient.Therefore, it is likely that the stent detached from the delivery wire during post-procedural handling/processing.The event description states that the vessel was extremely tortuous with an acute bend just proximal to the aneurysm location.Delivery of the device through difficult channels may cause impediment of the implant.Catheter obstructed is a known potential failure associated with the use of the device.The ifu contains cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.The yoga ifu cautions: ¿stop advancing the microcatheter if increased resistance is observed.Always determine the cause of resistance before proceeding, as resistance indicates possible blockage that can result in damage to the vessel and/or damage to the microcatheter.If the cause of the resistance cannot be determined, remove the microcatheter.¿ the bravo ifu cautions: ¿applying excessive force during delivery or retrieval of the system can potentially result in loss or damage to the device and delivery system components.Do not apply undue force if resistance is encountered at any time during implant manipulation.If excessive resistance is encountered, remove the entire system (microcatheter and bravo flow diverter).¿ neither the device history record review nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.Assignment of root cause for the event remains speculative and inconclusive, based on the information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including vessel characteristics (i.E.Excessive tortuosity, acute bends) and device manipulation, may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.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.The manufacturer will submit a supplemental report 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 flow diversion of a large cavernous fusiform recurrent anterior choroidal artery (acha) aneurysm, the yoga 32 xxb (mc32150zbx/c42462) microcatheter was tracked to the target aneurysm, but the 4.0x27mm bravo (fdc4027/11020352) flow diverter could not be advanced through the body of the microcatheter.The physician reportedly exerted a lot of force in an attempt to deliver the bravo through the yoga, and even utilized a torque device, but the bravo would not exit the microcatheter.The bravo and yoga were subsequently retrieved as a system from the patient, resulting in a loss of cerebral target position.Upon removal of the devices, the wire of the braid at the proximal end of the bravo was noted to have frayed.It was stated that ¿extensive forces were applied to the device which created friction and fraying on delivery wire (outside the body)¿.The bravo device was still on the delivery wire when removed from the patient.The devices were replaced, and the procedure was completed successfully.The bravo was replaced with a smaller bravo.No patient complications occurred as a result of the event.The five-minute delay in procedure was not considered clinically significant.The vessel was extremely tortuous with an acute bend just proximal to the aneurysm location.No visible product damage was noted prior to the event.The catheter did not appear damaged upon removal.There was no difficulty during introduction of the catheter over the guidewire prior to the attempted use of the bravo device.The user verified that the introducer was fully seated and secured in the hub during advancement.An adequate and continuous flush was maintained through the catheter.No further information could be obtained.

• Brand Name: MC 32, 150 CM, FLOWDIV, XXB
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): REFER TO SECTION H10; 3260 executive way; miramar FL 33025
• MDR Report Key: 8298149
• Report Number: 3008114965-2019-00903
• Device Sequence Number: 19330720
• Product Code: DQY
• UDI-Device Identifier: 10886704081296
• UDI-Public: 10886704081296
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K171653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2018

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: 04/30/2021
• Device Catalogue Number: MC32150ZBX
• Device Lot Number: C42462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1