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

Model Number 7164

Device Problem Contamination (1120)

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

Event Date 08/08/2023

Event Type  malfunction  

Event Description

It was reported that the device was not sterile.Upon opening the package of a 2.00 x 20 mm emerge, the sterile nurse noted that the inflation chart, located inside the sterile pouch, had some writing on the back.No damage was noted to the packaging or the seal of the sterile pouch.Since sterility of the product could not be confirmed, another balloon was used to complete the procedure per normal protocol.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer: returned product consisted of an emerge mr balloon catheter, its outer box packaging, inner tyvek packaging with shipping accessories, compliance chart label and instructions for use (ifu) booklet.The outer box, inner tyvek packaging, ifu booklet, and shipping hoop were visually examined.Inspection revealed no irregularity or damage.With no damage present, the device was removed from the hoop for analysis.The device was visually and microscopically examined.The balloon protector and shipping mandrel, with no damage, was present and removed without issue.There were no fluids within the device, and no visible damage.The balloon was tightly folded indicating that the device was not inflated.The compliance chart was reviewed and had writing on the back of the label.Photo media provided by the healthcare facility was reviewed and depicted a portion of the inner tyvek packaging, shipping hoop, and compliance chart label which contained writing to the back side of the label.No further damage or irregularity was detected with the media provided.

Event Description

It was reported that the device was not sterile.Upon opening the package of a 2.00 x 20 mm emerge, the sterile nurse noted that the inflation chart, located inside the sterile pouch, had some writing on the back.No damage was noted to the packaging or the seal of the sterile pouch.Since sterility of the product could not be confirmed, another balloon was used to complete the procedure per normal protocol.No patient complications were reported.

• Brand Name: EMERGE
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; pmt 741 persiaran cassia selat; bandarcassia, pulau pinan 14110 ; MY 14110
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17808222
• MDR Text Key: 324146229
• Report Number: 2124215-2023-52213
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7164
• Device Catalogue Number: 7164
• Device Lot Number: 0031090687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2023
• 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