MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) FIGHTER; CATHETER, GUIDEWIRE

Model Number	H749393031902
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).It is indicated that the device will not be returned for evaluation.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The cause of the reported difficulties could not be determined.(b)(4).
Event or Problem Description
It was reported that catheter entrapment occurred.The 98% stenosed target lesion was located in the mildly tortious and moderately calcified circumflex artery.Four balloon catheters had been delivered over the 190cm fighter guidewire and crossed the lesion successfully, but were not able to open the lesion.Then a non-bsc balloon catheter was used and inflated past rated burst pressure for four or five times.While trying to remove the balloon it became temporarily stuck on the guidewire.The physician ¿tortured¿ the balloon which may have been the reason for it not sliding off the wire easily.The balloon catheter was pulled out with the guidewire together.Once the devices were taken out, the balloon catheter was removed from the guidewire easily.Due to the complexity of the lesion it was decided to reassess the plan to open this lesion and the procedure was finished.No patient complications were reported and the patient¿s status was stable.

• Brand Name: FIGHTER
• Common Device Name: CATHETER, GUIDEWIRE
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• MDR Report Key: 6411010
• Report Number: 2134265-2017-02090
• Device Sequence Number: 16373340
• Product Code: DQX
• UDI-Device Identifier: 08714729886617
• UDI-Public: (01)08714729886617(17)20191019(10)19806444
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K151840
• 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): 02/27/2017

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: 10/19/2019
• Device Model Number: H749393031902
• Device Lot Number: 19806444
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2017
• Initial Report FDA Received Date: 03/16/2017
• 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: TERUMO TAZUNA BALLOON CATHETER