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

Model Number	7133
Medical Device Problem Codes	Contamination (1120); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device contamination occurred.The 70% stenosed, 5.0mmx 2.0mm, concentric, de novo target lesion was located in the non-tortuous and non-calcified right coronary artery.A 1.50mm x 15mm emerge balloon catheter was selected for use.However, a hole in the inner package was found and the sterility of the device got compromised.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an emerge balloon catheter in the packaging hoop, in the pouch.The pouch was open.Analysis of the pouch, tip, balloon, inner/outer shaft, and hypotube included microscopic and visual inspection.Inspection revealed an open pouch.Closer inspection of the edges/seal area of the pouch material found that the pouch material showed a continuous seal, without any open channels, rips, or tears.Inspection of the rest of the device found no other damage or defect.
Event or Problem Description
It was reported that device contamination occurred.The 70% stenosed, 5.0mmx 2.0mm, concentric, de novo target lesion was located in the non-tortuous and non-calcified right coronary artery.A 1.50mm x 15mm emerge balloon catheter was selected for use.However, a hole in the inner package was found and the sterility of the device got compromised.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.

• 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: 10631113
• Report Number: 2134265-2020-13244
• Device Sequence Number: 3620347
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2020

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: 03/05/2022
• Device Model Number: 7133
• Device Catalogue Number: 7133
• Device Lot Number: 0024074507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 10/05/2020
• Supplement Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 52