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

Model Number	7134
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 38mmx3mm target lesion was located in the mildly tortuous and moderately calcified circumflex artery.A 2.00mm x 20mm emerge balloon catheter was advanced for dilatation.However, the balloon ruptured.The device was completely removed from the patient and the procedure was completed with another of the same device.No patient complications were reported and patient's status was stable.
Additional Manufacturer Narrative
Returned product consisted of an emerge balloon catheter with the product mandrel still in the manufactured position.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual and microscopic examination revealed no damages.The balloon was tightly folded prior to inflation testing.The device was inflated to rated burst pressure and could hold pressure for 5 minutes.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis did not find any tear in the balloon.
Event or Problem Description
It was reported that balloon rupture occurred.The 38mmx3mm target lesion was located in the mildy tortuous and moderately calcified circumflex artery.A 2.00mm x 20mm emerge balloon catheter was advanced for dilatation.However, the balloon ruptured.The device was completely removed from the patient and the procedure was completed with another of the same device.No patient complications were reported and patient 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: 8148753
• Report Number: 2134265-2018-63737
• Device Sequence Number: 1437297
• Product Code: LOX
• UDI-Device Identifier: 08714729806301
• UDI-Public: 08714729806301
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2019

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: 11/02/2020
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0021834255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 01/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 68