MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK OCCLUDER¿; CATHETER, UROLOGICAL

Model Number	M0062201100
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an occluder occlusion balloon catheter was used during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the balloon came apart and had to be retrieved inside patient, though it is unknown how it was retrieved.At the conclusion of the procedure there was reported to be no harm to the patient.Attempts to obtain additional patient and procedure information have been unsuccessful.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Investigation results: visual evaluation of the complaint device found no defects noted on the balloon.However, the catheter shaft was broken at 64.5 cm from the distal tip of the balloon.Functional analysis could not be performed due to the condition of the device.Based on the condition of the returned device, the noted defects likely occurred due to anatomical or procedural factors which limited the performance of the balloon.Therefore, the most probable root cause is operational context.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications.A search of the complaint database revealed that no other complaints exist for the specified lot.A labeling review was performed and from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that an occluder occlusion balloon catheter was used during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the balloon came apart and had to be retrieved inside patient, though it is unknown how it was retrieved.At the conclusion of the procedure there was reported to be no harm to the patient.Attempts to obtain additional patient and procedure information have been unsuccessful.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: OCCLUDER¿
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• MDR Report Key: 6613153
• Report Number: 3005099803-2017-01678
• Device Sequence Number: 797128
• Product Code: KOD
• UDI-Device Identifier: 08714729161691
• UDI-Public: (01)08714729161691(17)20180731(10)0020251270
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K841941
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2017

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: 07/31/2018
• Device Model Number: M0062201100
• Device Catalogue Number: 220-110
• Device Lot Number: 0020251270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/22/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2017
• Supplement Report FDA Received Date: 06/20/2017
• 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: Required Intervention