MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA MISAGO RX SELF-EXPANDING PERIPHERAL STENT

Catalog Number	SX-FXA07X5LN
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The involved device was discarded by the involved facility and is not available for evaluation.Therefore, the investigation was limited to evaluation of user facility information and quality records.A review of the device history record and the product release decision control sheet of the involved product/lot# combination were conducted with no relevant findings.A review of the complaint history files confirmed that the involved product/lot# combination has not been reported previously.There is no evidence that this event was related to a device defect or malfunction.With no evaluation of the actual device, the cause of the reported event cannot be definitively determined.The device labeling does address the potential for such an occurrence in the instruction for use (ifu) with the statement such as the following: "as a guide, stent deployment commences on rolling back the thumbwheel 5-10 clicks for stents up to 100 mm long and 10-15 clicks for stents at least 120 mm long.Carefully roll back the thumbwheel one click at a time and adjust the position of the stent just prior to deployment if necessary (otherwise the stent can be deployed in the wrong position)." terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.Exemption number e2015022.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.H3 other text : actual device was discarded.
Event or Problem Description
The user facility reported a failure in the thumbwheel of the misago device.Follow up communication with the user facility confirmed the following information: the actual device was used in an sfa distal procedure for a very tortuous lesion; the stent reached the lesion without any difficulty; when the customer clicked the thumbwheel a strange resistance was noticed and it did not turn smoothly; after ten clicks the stent would not deploy; continued clicking of the thumbwheel with some force, the customer managed to place the stent in the lesion; another stent was added; the procedure was completed successfully; and the patient was not harmed.

• Brand Name: MISAGO RX SELF-EXPANDING PERIPHERAL STENT
• Common Device Name: STENT
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 5537707
• Report Number: 9681834-2016-00066
• Device Sequence Number: 10832698
• Product Code: NIP
• UDI-Device Identifier: 04987350722263
• UDI-Public: 04987350722263
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P140002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: SX-FXA07X5LN
• Device Lot Number: 131225
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2016
• Initial Report FDA Received Date: 03/31/2016
• 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: STENT; STENT
• Outcome Attributed to Adverse Event: Other