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

Model Number 7920

Device Problems Difficult to Remove (1528); Material Integrity Problem (2978); Positioning Problem (3009)

Patient Problem Vasoconstriction (2126)

Event Date 10/07/2019

Event Type  Injury  

Event 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was snared to provide tension and allow a wire to pass through to unloop and unkink the catheter.The catheter was withdrawn and discarded.The procedure was completed with non-bsc device.There were no patient complications reported.The patient is in a stable and good condition.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
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): AVAIL MEDICAL PRODUCTS INCORPO
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9186257
• MDR Text Key: 162498337
• Report Number: 2134265-2019-12332
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 08714729152996
• UDI-Public: 08714729152996
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K120495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention