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	12/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6) hospital.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed, 3.0-3.5mmx18-20mm target lesionn was located in the severely tortuous and moderately calcified left anterior descending artery.A 2.00mm x 20mm emerge balloon catheter was advanced for dilatation.However, during inflation at 10 atmospheres, the balloon ruptured.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status was stable.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed, 3.0-3.5mmx18-20mm target lesionn was located in the severely tortuous and moderately calcified left anterior descending artery.A 2.00mm x 20mm emerge balloon catheter was advanced for dilatation.However, during inflation at 10 atmospheres, the balloon ruptured.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
Evaluation conclusion codes: updated from "cmc - adverse event related to procedure" to "no problem detected".Initial reporter facility name: (b)(6) hospital.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 118.4cm from the tip and appears to have been kinked prior to separating.The hub and the proximal section of the hypotube is missing.There are multiple kinks along the hypotube.Microscopic examination revealed damage to the inflation lumen.There is contrast present in the inflation lumen and blood present in the guidewire lumen.The balloon is still tightly folded.There is no indication the device was inflated over rated burst pressure.The hypotube was connected to a touhy adaptor and the balloon was inflated to rated burst pressure for 5 minutes.No leaks or ruptures were noticed.Inspection of the remainder of the device presented no other damage or irregularities.
Additional Manufacturer Narrative
(b)(6).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 118.4cm from the tip and appears to have been kinked prior to separating.The hub and the proximal section of the hypotube is missing.There are multiple kinks along the hypotube.Microscopic examination revealed damage to the inflation lumen.There is contrast present in the inflation lumen and blood present in the guidewire lumen.The balloon is still tightly folded.The hypotube was connected to a touhy adaptor and the balloon was inflated to rated burst pressure for 5 minutes.No leaks or ruptures were noticed.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed, 3.0-3.5mmx18-20mm target lesionn was located in the severely tortuous and moderately calcified left anterior descending artery.A 2.00mm x 20mm emerge balloon catheter was advanced for dilatation.However, during inflation at 10 atmospheres, the balloon ruptured.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: 8313551
• Report Number: 2134265-2019-00911
• Device Sequence Number: 2198329
• 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,Followup
• Report Date (Section B): 05/07/2019

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: 01/12/2021
• Device Model Number: 7134
• Device Catalogue Number: 7134
• Device Lot Number: 0022137755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 03/28/2019; 04/18/2019
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 04/17/2019; 05/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 140