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

Model Number	7885
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that catheter fracture occurred.The target lesion was located in the aorta artery.A 110 cm impulse diagnostic catheter was selected for use.Resistance was encountered during advancement.The catheter was removed and it was observed to be fractured.The device was completely removed from the patients body.The procedure was completed with a different device.No patient complications were reported and the patients status was stable.
Additional Manufacturer Narrative
Mfg.Address 2 - no.20905 int.A.Col.,cd.Industrial, 22444.Device evaluated by mfr.: returned product consisted of an impulse catheter.Analysis of the tip, shaft, and hub/strain relief included microscopic and visual inspection.Inspection revealed kink in the device located 1mm and 53.5cm from the hub.Inspection of the rest of the device found no other damage or defect.
Event or Problem Description
It was reported that catheter fracture ocurred.The target lesion was located in the aorta artery.A 110cm impulse diagnostic catheter was selected for use.Resistance was encountered during advancement.The catheter was removed and it was observed to be fractured.The device was completely removed from the patients body.The procedure was completed with a different device.No patient complications were reported and the patients 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: 8650577
• Report Number: 2134265-2019-05861
• Device Sequence Number: 2075388
• 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
• Report Date (Section B): 09/30/2019

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: 09/06/2020
• Device Model Number: 7885
• Device Catalogue Number: 7885
• Device Lot Number: 0060147375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1