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

Model Number	7132
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that sterility was compromised.During preparation of a 1.50mm x 12mm emerge balloon catheter, it was noted that the inner package was damaged and there was no sterile environment.The device was not used inside the patient and the procedure was completed with another of the same device.There were no complications reported and the patient was stable.
Event or Problem Description
It was reported that sterility was compromised.During preparation of a 1.50mm x 12mm emerge balloon catheter, it was noted that the inner package was damaged and there was no sterile environment.The device was not used inside the patient and the procedure was completed with another of the same device.There were no complications reported and the patient was stable.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.The pouch was opened at the poly/tyvek vendor seal.There were numerous kinks.There was a complete separation at 77.2cm distal of the strain relief.There was blood in the guidewire lumen.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: EMERGE
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11131298
• Report Number: 2134265-2020-18542
• Device Sequence Number: 16978030
• Product Code: LOX
• UDI-Device Identifier: 08714729806073
• UDI-Public: 08714729806073
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2021

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: 06/28/2022
• Device Model Number: 7132
• Device Catalogue Number: 7132
• Device Lot Number: 0024695422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Initial Date Received by Manufacturer: 12/20/2020
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 70