MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; CATHETER, PERCUTANEOUS

Catalog Number 3933013

Device Problem Deflation Problem (1149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2022

Event Type  malfunction  

Event Description

Three separate trapper balloon devices failed to hold pressure in the balloon.Manufacturer response for trapper exchange device 6f-8f, (brand not provided) (per site reporter) issued rga# (b)(4), sending in n/c replacements.Manufacturer response for trapper exchange device 6f - 8f, (brand not provided) (per site reporter) issued rga# (b)(4), sending in n/c replacements.Manufacturer response for trapper exchange device 6f -8f, (brand not provided) (per site reporter) issued rga# (b)(4), sending in n/c replacements.

• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 15635760
• MDR Text Key: 302067175
• Report Number: 15635760
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/29/2022

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 Catalogue Number: 3933013
• Device Lot Number: 357103-0756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28105 DA
• Patient Sex: Male