MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SAVION FLX; WIRE, GUIDE, CATHETER

Model Number	1006
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date was approximated.
Event or Problem Description
It was reported that a tip separation occurred.A savion flx guidewire was selected for use.During preparation outside the patient, the physician attempted to gently shape the distal tip.No strength was used and no resistance was felt while trying to shape the tip; however the distal tip broke and tore apart.The product was not used inside the patient and there were no patient complications reported.
Event or Problem Description
It was reported that a tip separation occurred.A savion flx guidewire was selected for use.During preparation outside the patient, the physician attempted to gently shape the distal tip.No strength was used and no resistance was felt while trying to shape the tip; however the distal tip broke and tore apart.The product was not used inside the patient and there were no patient complications reported.
Additional Manufacturer Narrative
Event date was approximated.Device evaluated by mfr: the unit was returned with its original pouch and has distal tip damage.The device was broken 183.2 cm from proximal to the broken section, overall should be 185 cm.The other part of the wire was not returned.On the other hand, the device was kinked at the distal tip.Overall length inspection couldn't be performed due to the condition of the device.Outer diameter dimensional inspections of the distal tip, middle of the device and proximal section were all within specifications.

• Brand Name: SAVION FLX
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8528076
• Report Number: 2134265-2019-03988
• Device Sequence Number: 2384629
• Product Code: DQX
• UDI-Device Identifier: 08714729978831
• UDI-Public: 08714729978831
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K964551
• 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
• Report Date (Section B): 05/30/2019

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: 07/31/2020
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0022457547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 05/30/2019
• Patient Sequence Number: 1