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

Model Number	7133
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an emerge balloon catheter.The packaging, shaft, hypotube, tip and balloon were microscopically and visually examined.The pouch was opened along the vendor seal.There were numerous kinks.There was a complete separation at 20.3cm distal of the strain relief.There was contrast and blood in the inflation lumen, and blood in the guidewire lumen.The balloon was tightly folded.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on 21-jan-2021 it was reported that the packaging was damaged.A percutaneous coronary intervention was being performed.A 1.50mm x 15mm emerge balloon catheter was selected for use.However, the physician found that the package was damaged.There were no patient complications reported and the patient's status was stable.However, returned device analysis revealed shaft detached/separated.

• 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: 11329800
• Report Number: 2134265-2021-00927
• Device Sequence Number: 1045946
• Product Code: LOX
• UDI-Device Identifier: 08714729806189
• UDI-Public: 08714729806189
• 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
• Report Date (Section B): 02/15/2021

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: 12/19/2022
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0025464530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 66