MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION, MARINA BAY CUST. FULFILLMENT PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number PCB7020135

Device Problems Detachment Of Device Component (1104); Migration or Expulsion of Device (1395)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/24/2016

Event Type  malfunction  

Event Description

Dr.Was performing an av fistulogram with angioplasty utilizing a boston scientific 7mm/2cm peripheral cutting balloon.While trying to remove the deflated balloon through the sheath, the balloon separated from the catheter.Attempt was made to retrieve the balloon with a snare to no avail.The balloon migrated into the right pulmonary artery.Dr.Has made contact with the transfer center to have the patient transferred for retrieval.The patient was stable and was escorted back to her room with radiology nursing in attendance.The reference# for the balloon is pcb7020135, lot# 19410473, expiration date 6/24/2018.The remaining catheter has been secured.

• Brand Name: PERIPHERAL CUTTING BALLOON
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION, MARINA BAY CUST. FULFILLMENT; 500 commander shea boulevard; quincy MA 02171
• MDR Report Key: 6036714
• MDR Text Key: 57761307
• Report Number: 6036714
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PCB7020135
• Device Lot Number: 19410473
• Other Device ID Number: UPN-M001PCB70201350
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/02/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other