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

Model Number	H7493896115150
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a coronary artery.A 1.50mm x 15mm apex¿ push balloon catheter was advanced for dilatation; however, the balloon could not inflate as it ruptured.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
Returned product consisted of an apex balloon catheter.There was contrast in the inflation lumen.The balloon was tightly folded.Microscopic examination of the balloon and shaft did not reveal any tears or damage.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device to rated burst pressure for 5 minutes.The catheter maintained constant pressure and there was no indication of any leaks or other irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is not confirmed as there was no evidence of the alleged issue or any anomalies which could have contributed to the reported difficulty.(b)(4).
Event or Problem Description
It was further reported that the device was completely removed from the patient's body.

• Brand Name: APEX¿ PUSH
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 6580185
• Report Number: 2134265-2017-05022
• Device Sequence Number: 10966546
• Product Code: LOX
• UDI-Device Identifier: 08714729476009
• UDI-Public: (01)08714729476009(17)20181031(10)18507285
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: P860019
• 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): 05/04/2017

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: 10/31/2018
• Device Model Number: H7493896115150
• Device Catalogue Number: 38961-1515
• Device Lot Number: 18507285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/04/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2017
• Supplement Report FDA Received Date: 06/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1