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

Model Number 7885

Device Problems Fracture (1260); Difficult to Advance (2920); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event 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.

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 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.

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 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
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8722987
• MDR Text Key: 148795868
• Report Number: 2134265-2019-07167
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729343639
• UDI-Public: 08714729343639
• Combination Product (y/n): N
• PMA/PMN Number: K120495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 06/05/2019
• Initial Date FDA Received: 06/21/2019
• Supplement Dates Manufacturer Received: 06/28/2019; 08/26/2019
• Supplement Dates FDA Received: 07/22/2019; 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1