MAUDE Adverse Event Report: REFER TO SECTION H10 MC 28, 150 CM, XB; CATHETER, PERCUTANEOUS

Catalog Number	MC28150ZB
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).(b)(6).Initial reporter - the customer contact information, including phone, fax, and e-mail address, was not reported.It was not reported whether the complaint product is available for evaluation and testing and it has not been received to date (which is indicated as "other").Additional information will be submitted within 30 days of receipt.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 right internal carotid artery (ica) aneurysm, the yoga 28 xb (mc28150zb/c42465) microcatheter was advanced successfully passed the aneurysm location, but the bravo flow diverter (fdc4023/unk lot) came to a stop at the carotid syphon in the yoga microcatheter.The physician replaced the yoga 28 microcatheter with a yoga 32 microcatheter and the procedure was completed without further incident.No patient complications occurred as a result of the event.It was not reported whether the product will be returned for evaluation.No further information was provided.
Additional Manufacturer Narrative
(b)(4).As reported by a healthcare professional, during a flow diversion of a right internal carotid artery (ica) aneurysm, the yoga 28 xb (b)(4) microcatheter was advanced successfully passed the aneurysm location, but the bravo flow diverter ((b)(4)/unk lot) came to a stop at the carotid syphon in the yoga microcatheter.The physician replaced the yoga 28 microcatheter with a yoga 32 microcatheter and the procedure was completed without further incident.No patient complications occurred as a result of the event.Multiple attempts were made without success to obtain additional information.A non-sterile mc yoga 28xb was received inside of a pouch.The catheter was visually inspected, and no damage was noted to the hub and distal tip; however, the body of the catheter was found kinked at 132 centimeters (cm) from the distal end.No additional damage was observed.The inner diameter (id) and outer diameter (od) of the microcatheter were measured and results were found within specification.The catheter was flushed with a lab sample syringe and a lab sample sv-5 (cordis) guidewire was introduced into the catheter.The guidewire advanced smoothly until the distal tip of the microcatheter.Resistance/friction was encountered when the guidewire was advanced through the kinked section of the catheter body.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 reported customer complaint of catheter obstructed was not confirmed during functional analysis as there were no obstructions noted in the received device; however, resistance/friction was felt as the sample guidewire was passed through the kinked section of the catheter.The exact circumstances surrounding the observed damage to the catheter cannot be determined based on the condition of the returned device; however, it is possible that the kink may have occurred during storage, shipping, or processing after the reported event.Catheter obstructed is a known potential product failure associated with the use of the device.The instructions for use (ifu) contains several cautions relating to this situation, including instructions for troubleshooting the situation should it be encountered during use.Without the return of the concomitant device, the cause of the reported event cannot be identified.Neither the product analysis nor the device history review suggests that the 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 minimal information provided and the evidence presented by the returned catheter; however, it is possible that procedural and handling factors, including 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report that the product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: MC 28, 150 CM, XB
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): REFER TO SECTION H10; 3260 executive way; miramar FL 33025
• MDR Report Key: 8073977
• Report Number: 3008114965-2018-00808
• Device Sequence Number: 19255883
• Product Code: DQY
• UDI-Device Identifier: 10886704079415
• UDI-Public: 10886704079415
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup,Followup
• Report Date (Section B): 11/07/2018

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: 05/31/2021
• Device Catalogue Number: MC28150ZB
• Device Lot Number: C42465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Initial Date Received by Manufacturer: 11/07/2018
• Supplement Date Received by Manufacturer: 12/05/2018; 12/14/2018
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 12/12/2018; 01/04/2019
• 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: REFER TO SECTION H10.
• Patient Age: 49 YR