MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OCCLUDER; CATHETER, UROLOGICAL

Model Number M0062201080

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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

It was reported to boston scientific corporation that an occlusion balloon catheter was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6) 2020.According to the complainant, during preparation, the balloon was able to be inflated with saline; however, the balloon could not be deflated completely after several attempts.The procedure was completed with another occlusion balloon catheter.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation that an occlusion balloon catheter was used in the kidney during a percutaneous nephrolithotomy (pcnl) procedure performed on (b)(6), 2020.According to the complainant, during preparation, the balloon was able to be inflated with saline; however, the balloon could not be deflated completely after several attempts.The procedure was completed with another occlusion balloon catheter.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: problem code 1149 captures the reportable event of balloon failed to deflate.Block h10: investigation results visual examination of the returned complaint device revealed no visual defects and was in a good condition.No damage was found on the catheter of the device.Functional analysis was performed, the balloon was inflated and deflated without issues.There were no leaks, holes or pinholes noted in the balloon.It was also noted that the balloon was able to hold the pressure.The returned device review (visual, physical, and performance testing) showed no evidence of either the alleged or any defect which could have contributed to the event.Therefore, the most probable root cause for this complaint cannot be detected.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.A labeling review was performed and from the information available, this device was used per the instructions for use (ifu)/product label.

• Brand Name: OCCLUDER
• Type of Device: CATHETER, UROLOGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10570592
• MDR Text Key: 208124639
• Report Number: 3005099803-2020-04139
• Device Sequence Number: 1
• Product Code: EYB
• UDI-Device Identifier: 08714729191995
• UDI-Public: 08714729191995
• Combination Product (y/n): N
• PMA/PMN Number: K133750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/04/2021
• Device Model Number: M0062201080
• Device Catalogue Number: 220-108
• Device Lot Number: 0024863884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1