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

Model Number H7493919312250

Device Problems Detachment Of Device Component (1104); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that tip detachment occurred.During unpacking of a 2.50mm x 12mm emerge¿ balloon catheter, it was noted that the proximal tip of the device was twisted on its proximal section and upon removal from the sheath, the tip detached from the rest of the catheter.The sheath and the packaging were intact.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an emerge balloon catheter with no other devices.The balloon was tightly folded.The balloon protector was over the balloon and the product mandrel was in the lumen.The distal tip was not damaged and was still attached to the catheter.The hypotube was completely separated at the strain relief.The fracture faces were oval as if kinked prior to separation.There were numerous hypotube kinks.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

It was reported that tip detachment occurred.During unpacking of a 2.50mm x 12mm emerge¿ balloon catheter, it was noted that the proximal tip of the device was twisted on its proximal section and upon removal from the sheath, the tip detached from the rest of the catheter.The sheath and the packaging were intact.No patient complications were reported.

• 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: 7117012
• MDR Text Key: 94947707
• Report Number: 2134265-2017-12323
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K113220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2020
• Device Model Number: H7493919312250
• Device Catalogue Number: 39193-1225
• Device Lot Number: 21120231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2017
• 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