MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 7163

Device Problem Unsealed Device Packaging (1444)

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

Event Date 06/14/2021

Event Type  malfunction  

Event Description

It was reported that the packaging seal was compromised.During preparation, a hole was observed on the inner packaging seal of the 3.00mm and 15mm emerge balloon product pouch.The emerge balloon was not used for the procedure.The procedure was successfully completed with another 3.00mm x 15mm emerge balloon.No patient harm resulted in relation to this event.

Manufacturer Narrative

Device evaluated by manufacturing: returned product consisted of an emerge balloon catheter and its originally shipped packaging and outer box.The product pouch was visually inspected.The product pouch contained a unit for batch 27254961 and there was no bsc seal.The batch number on the returned packaging was 27254961.The tyvek seal was inspected, and it was still intact.It was verified that the packaging was not sealed when it left manufacturing facility.Inspection of the remainder of the packaging and device presented no other damage or irregularities.Product analysis found there was an open seal.

Event Description

It was reported that the packaging seal was compromised.Event summary: during preparation, a hole was observed on the inner packaging seal of the 3.00mm and 15mm emerge balloon product pouch.The emerge balloon was not used for the procedure.The procedure was successfully completed with another 3.00mm x 15mm emerge balloon.Patient status: no patient harm resulted in relation to this event.

• Brand Name: EMERGE
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12033330
• MDR Text Key: 257191126
• Report Number: 2134265-2021-07902
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• 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: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 7163
• Device Catalogue Number: 7163
• Device Lot Number: 0027254961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Date Manufacturer Received: 07/21/2021
• Patient Sequence Number: 1