MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE EMERGE¿; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number H7493919315150

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

It was reported that balloon tear occurred.The 95% stenosed target lesion containing a severe bend was located in a severely tortuous and severely calcified left anterior descending artery.A 1.50mm x 15mm emerge¿ balloon catheter was advanced but failed to cross the lesion due to calcification and angulation.However, it was noted that the balloon ends were split.The procedure was completed with another with same device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an emerge balloon catheter.The outer shaft, inner shaft, balloon and tip were microscopically examined.The tip is damaged.There is shaft damage at the exit notch that is consistent with damage seen with the use of a guide wire.Functional testing was carried out by attaching an inflation device filled with water to the hub of the complaint device, and inflating the device to rated burst pressure.The device inflated and held pressure for 5 minutes without leaking.Inspection of the remainder of the device presented no other damage or irregularities.There was no evidence of any material or manufacturing deficiencies contributing to the confirmed tip damage and the reported difficulty.The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was further reported that following removal of the device, it was noted that the tip of the device was cracked/damaged.The patient's status was stable.

• Brand Name: EMERGE¿
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7524472
• MDR Text Key: 108636503
• Report Number: 2134265-2018-04474
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: KR
• PMA/PMN Number: K113220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2020
• Device Model Number: H7493919315150
• Device Catalogue Number: 39193-1515
• Device Lot Number: 21664084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/17/2018
• Supplement Dates Manufacturer Received: 05/23/2018
• Supplement Dates FDA Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR