MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENCORE 26; SYRINGE, BALLOON INFLATION

Model Number M0067101140

Device Problems Mechanical Problem (1384); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2020

Event Type  malfunction  

Manufacturer Narrative

User facility/importer report# (b)(4).(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

Note: this report pertains to an encore inflation device and a nephromax dilatation balloon catheter used in the same patient and procedure.It was reported to boston scientific corporation that an encore inflation device and a nephromax dilatation balloon catheter were used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the balloon burst when inflated to 16 psi.Subsequently, the inflation medium of the balloon was found filling the retroperitoneum of the patient which made the image of the kidney under fluoroscopy too challenging to see.Reportedly, there are two wires in the kidney at that time.The encore inflation device was noted hard to use.The procedure was not completed due to this event, and the patient had to be brought back to the hospital at a later date for another procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: ENCORE 26
• Type of Device: SYRINGE, BALLOON INFLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 10850696
• MDR Text Key: 216615394
• Report Number: 3005099803-2020-05510
• Device Sequence Number: 1
• Product Code: MAV
• UDI-Device Identifier: 08714729755814
• UDI-Public: 08714729755814
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K955869
• 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: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2023
• Device Model Number: M0067101140
• Device Catalogue Number: 710-114
• Device Lot Number: 0025522830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2020
• 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 Age: 57 YR