MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) DREAMWIRE¿; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number	M00556161
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).Visual examination of the returned guidewire revealed that it was broken and kinked at 152.7cm from the distal end and the broken section length was 297.6cm.Both sections have the ptfe peeled along the device exposing the corewire.The complaint is consistent with the reported event of guidewire kinked.Probably procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.It is most likely that during procedure the device could have been manipulated, since the failures found are issues that could have been generated through excessive manipulation of the device, also interaction with other devices might have impacted the integrity of the device during the procedure.Therefore, the most probable cause of this complaint is operational context since probably due to anatomical/procedural factors encountered during the procedure, performance was limited.A dhr (device history record) review was performed and no deviation was found.A search of the complaint database confirmed that no similar complaints exist for the specified batch.
Event or Problem Description
It was reported to boston scientific corporation that a dreamwire¿ guidewire was used during a pseudocyst drainage procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the guidewire would not pass smoothly.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient¿s condition at the conclusion of the procedure was reported to be stable.Investigation results revealed on january 17, 2018 that the core wire was broken.

• Brand Name: DREAMWIRE¿
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7216711
• Report Number: 3005099803-2018-00207
• Device Sequence Number: 13486749
• Product Code: EZB
• UDI-Device Identifier: 08714729777861
• UDI-Public: 08714729777861
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/17/2018

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: 04/06/2019
• Device Model Number: M00556161
• Device Catalogue Number: 5616
• Device Lot Number: 19116984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 01/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1