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

Model Number 7133

Device Problems Contamination (1120); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 09/15/2020

Event Type  malfunction  

Event 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.

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 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
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10631113
• MDR Text Key: 210385699
• Report Number: 2134265-2020-13244
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 08714729806189
• UDI-Public: 08714729806189
• Combination Product (y/n): N
• PMA/PMN Number: K121196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 52