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

Model Number	7920
Medical Device Problem Codes	Difficult to Remove (1528); Material Integrity Problem (2978); Positioning Problem (3009)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	10/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experience a vasospam and the catheter became looped within the artery.The target lesion was located in right coronary artery.An impulse diagnostic catheter was selected for use to view the target lesion.The catheter was prepped as usual and was advanced to image the right coronary artery.However, the physician lost torque of the catheter during engagement of the target lesion and imaged the arm.An arterial spasm occurred which resulted in the catheter looping in the radial artery.The catheter became twisted and kinked distal to the sheath.Subsequently, a femoral puncture and entry was made to attempt to unkink and unloop the catheter in the radial artery.The catheter was snared to provide tension and allow a wire to pass through to unloop and unkink the catheter.The catheter was withdrawn and discarded.The procedure was completed with non-bsc device.There were no patient complications reported.The patient is in a stable and good condition.

• 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: 9186257
• Report Number: 2134265-2019-12332
• Device Sequence Number: 11625041
• Product Code: DQO
• UDI-Device Identifier: 08714729152996
• UDI-Public: 08714729152996
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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
• Report Date (Section B): 10/14/2019

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: 05/23/2021
• Device Model Number: 7920
• Device Catalogue Number: 7920
• Device Lot Number: 0060186856
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 10/14/2019
• 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: Other; Required Intervention