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

Model Number 7880

Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/03/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that catheter separation occurred.The target lesion was located in the aorta.A 5f 145 110 cm impulse guide catheter was selected for use during procedure.It was observed that the impulse catheter separated at the 145 degree bend.Subsequently, a snare was advanced through the femoral access and the detached catheter's tip was retrieved.The device was completely removed from the patient's body.There were no patient complications reported.Patient is stable.

Event Description

It was reported that catheter separation occurred.The target lesion was located in the aorta.A 5f 145 110cm impulse guide catheter was selected for use during procedure.It was observed that the impulse catheter separated at the 145 degree bend.Subsequently, a snare was advanced through the femoral access and the detached catheter's tip was retrieved.The device was completely removed from the patient's body.There were no patient complications reported.Patient is stable.

Manufacturer Narrative

(b)(6).Device evaluated by mfr: the device was returned in two pieces.Analysis of the tip and shaft included microscopic, visual and sem inspection.Inspection revealed a complete separation of the shaft located 5.5 cm from the distal end.The separated ends were run through an electron microscope and the edge of the distal separated edge found full bond edge with evidence of tensile forcep applied to device.Inspection of the rest of the device found no other damage or defect.

• Brand Name: IMPULSE GUIDE CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9109982
• MDR Text Key: 161243837
• Report Number: 2134265-2019-11572
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729153160
• UDI-Public: 08714729153160
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2021
• Device Model Number: 7880
• Device Catalogue Number: 7880
• Device Lot Number: 0060195229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Date Manufacturer Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention