MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 11/13/2018

Event Type  Death  

Event Description

It was reported that the patient died post procedure.A solent proxi catheter and a 2cm peripheral cutting balloon (pcb) was selected for use for an arteriovenous graft thrombectomy procedure in the left arm.The target lesion was stenosed with a clot.The solent proxi catheter was used to remove the clot.The physician then used the pcb to balloon the graft.The angiojet catheter was used again.The physician performed ballooning again and was continuing the angioplasty when the patient began to code.The procedure was not completed.The total amount aspirated with angiojet during the procedure was 425cc.There were no device issues or defects noted during the procedure.The patient complications were a massive pulmonary embolism.The patient died.The official cause of death was unknown.The physician did not think that the two devices contributed to the patient's death.

• Brand Name: PERIPHERAL CUTTING BALLOON
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8116260
• MDR Text Key: 128783559
• Report Number: 2134265-2018-63269
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070951
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death