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

Model Number	7880
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9109982
• Report Number: 2134265-2019-11572
• Device Sequence Number: 3173516
• Product Code: DQO
• UDI-Device Identifier: 08714729153160
• UDI-Public: 08714729153160
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K120495
• 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,Followup
• Report Date (Section B): 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 09/05/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention