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

Model Number	7134
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an emerge balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the hypotube is separated 85.7cm from the hub.There are multiple kinks along the hypotube.Microscopic examination revealed damage to the tip.There is contrast present in the inflation lumen and balloon.There is blood present in the guidewire lumen inflation lumen.The balloon was loosely folded prior to pressure testing.The device was unable to inflate so it was placed in a water bath on (b)(6) 2019 to soften the contrast and blood present inside the device.The device was inflated to rated burst pressure.No leaks were found.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary artery.A 3.00mm x 20mm emerge balloon catheter was advanced for pre-dilatation.However, the balloon failed to inflate.An attempt to remove the device was made and found the shaft broken.The device cannot be pulled out initially and was then removed by inflating another balloon behind it while pulling it out.The procedure was completed with another of the same device.No patient complications were reported and the patient was fine.
Event or Problem Description
It was reported that shaft break occurred.The target lesion was located in a coronary artery.A 3.00mm x 20mm emerge balloon catheter was advanced for pre-dilatation.However, the balloon failed to inflate.An attempt to remove the device was made and found the shaft broken.The device cannot be pulled out initially and was then removed by inflating another balloon behind it while pulling it out.The procedure was completed with another of the same device.No patient complications were reported and the patient was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an emerge balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the hypotube is separated 85.7cm from the hub.There are multiple kinks along the hypotube.Microscopic examination revealed damage to the tip.There is contrast present in the inflation lumen and balloon.There is blood present in the guidewire lumen inflation lumen.The balloon was loosely folded prior to pressure testing.The device was unable to inflate so it was placed in a water bath on (b)(6) 2019 to soften the contrast and blood present inside the device.The device was inflated to rated burst pressure.No leaks were found.Inspection of the remainder of the device presented no other damage or irregularities.- (b)(4).

• 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: 8568673
• Report Number: 2134265-2019-04422
• Device Sequence Number: 1639592
• Product Code: LOX
• UDI-Device Identifier: 08714729806349
• UDI-Public: 08714729806349
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K113220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/02/2021
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0023295288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR