MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IMPULSE; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	7885
Medical Device Problem Codes	Fracture (1260); Difficult to Advance (2920); Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that tip fracture occurred.An impulse catheter was selected for use.During the procedure outside the patient, it was observed that the tip was fractured and the device would not advance.The procedure was competed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
Correction.Initially reported device code fracture 1260 based on additional information received on 28june2019, the device code has been updated to material deformation 2976.G1: mfr site address 2: no.20905 int.A.Col., cd.Industrial, 22444.
Event or Problem Description
It was reported that tip fracture occurred.An impulse catheter was selected for use.During the procedure outside the patient, it was observed that the tip was fractured and the device would not advance.The procedure was completed with another of the same device.There were no patient complications reported.It was further reported that the tip was observed to be kinked and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by manufacturer; analysis of the hub, shaft and tip included microscopic and visual inspection.Analysis revealed kinks in the shaft located 2.4cm, 5.5cm and 66cm from the tip of the device.Inspection of the rest of the device found no other damage.G1: mfr site address 2: no.20905 int.A.Col., cd.Industrial, 22444.
Event or Problem Description
It was reported that tip fracture occurred.An impulse catheter was selected for use.During the procedure outside the patient, it was observed that the tip was fractured and the device would not advance.The procedure was completed with another of the same device.There were no patient complications reported.It was further reported that the tip was observed to be kinked and the patient's status was stable.

• Brand Name: IMPULSE
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8722987
• Report Number: 2134265-2019-07167
• Device Sequence Number: 13885500
• Product Code: DQO
• UDI-Device Identifier: 08714729343639
• UDI-Public: 08714729343639
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K120495
• 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,Followup
• Report Date (Section B): 09/19/2019

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: 11/16/2020
• Device Model Number: 7885
• Device Catalogue Number: 7885
• Device Lot Number: 0060160123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Initial Date Received by Manufacturer: 06/05/2019
• Supplement Date Received by Manufacturer: 06/28/2019; 08/26/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 07/22/2019; 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1