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

Model Number	7925
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	09/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that bronchial spasms occurred during use of a 5f impulse fr3.5 catheter.The device was removed and no further complications were reported.
Event or Problem Description
It was reported that bronchial spasms occurred during use of a 5f impulse fr3.5 catheter.The device was removed and no further complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Analysis of returned product revealed that inspection revealed tip damage (ovalized).No other issues or defects were observed during product analysis of the returned device.

• 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: 7992250
• Report Number: 2134265-2018-61693
• Device Sequence Number: 16537130
• Product Code: DQO
• UDI-Device Identifier: 08714729213161
• UDI-Public: 08714729213161
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 07/09/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/12/2020
• Device Model Number: 7925
• Device Catalogue Number: 7925
• Device Lot Number: 0060117195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 10/22/2018
• Supplement Report FDA Received Date: 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1