MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLSTENT¿ RP ENDOPROSTHESIS; STENT, CORONARY

Model Number	M001712320
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that catheter entrapment occurred.The 90% stenosed target lesion was located in the mildly tortuous and moderately calcified left common iliac artery.A 10x20x75mm wallstent¿ rp endoprosthesis was deployed to the lesion.However, a non-bsc guide wire became stuck with the guide wire lumen.The guide wire was removed and a "yellow object" part of the wall was noted sticking to the guide wire.The device could not be retrieved due to infectious disease and the procedure was completed.No patient complications nor injuries were reported.

• Brand Name: WALLSTENT¿ RP ENDOPROSTHESIS
• Common Device Name: STENT, CORONARY
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7403861
• Report Number: 2134265-2018-02833
• Device Sequence Number: 1575375
• Product Code: MAF
• UDI-Device Identifier: 08714729345862
• UDI-Public: 08714729345862
• Combination Product (Y/N): N
• PMA/510(K) Number: P940019
• 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): 03/14/2018

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 Model Number: M001712320
• Device Catalogue Number: 71-232
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2018
• Initial Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1