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

Model Number	7142
Medical Device Problem Codes	Contamination (1120); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that device contamination occurred.A 1.50mm x 12mm emerge balloon catheter was selected for use.However, it was found that the inner packaging was damaged, and the device sterility was compromised.The procedure was completed with another of same device without any patient complications reported.The patient was stable.
Event or Problem Description
It was reported that device contamination occurred.A 1.50mm x 12mm emerge balloon catheter was selected for use.However, it was found that the inner packaging was damaged, and the device sterility was compromised.The procedure was completed with another of same device without any patient complications reported.The patient was stable.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).
Event or Problem Description
It was reported that device contamination occurred.A 1.50mm x 12mm emerge balloon catheter was selected for use.However, it was found that the inner packaging was damaged, and the device sterility was compromised.The procedure was completed with another of same device without any patient complications reported.The patient was stable.
Additional Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Device evaluated by mfr.: the fg emerge otw, us 1.50mm x 12mm stent delivery system was returned for analysis.Visual, tactile and microscopic analysis was performed on the device.No issues identified with the hypotube shaft and no issues were identified with the outer / mid-shaft sections or the inner lumen of the device.The balloon cones were reviewed, and no issues were noted.The bumper tip showed no signs of distal tip damage.No device issues were identified during the returned product analysis.There was no evidence of any device use, and no device packaging was returned for analysis.

• Brand Name: EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19910949
• Report Number: 2124215-2024-48223
• Device Sequence Number: 8867212
• Product Code: LOX
• UDI-Device Identifier: 08714729806684
• UDI-Public: 08714729806684
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/04/2024
• Device Model Number: 7142
• Device Catalogue Number: 7142
• Device Lot Number: 0030286059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 09/02/2024; 10/10/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 09/19/2024; 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 74 KG