MAUDE Adverse Event Report: MEDTRONIC SPRINTER 3.0 MM X 12 MM BALLOON; RAPID EXCHANGE BALLOON DILATION CATH

Model Number SPL30012X

Device Problems Material Fragmentation (1261); Material Rupture (1546)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/14/2015

Event Type  Injury  

Event Description

During a coronary intervention a medtronic 3.0 x 12 mm sprinter legend balloon ruptured during inflation.Upon removal of device half of balloon was missing and suspected to still be in the pt.Upon picture we were able to visualize the balloon piece and placed a drug eluting stent over the balloon piece in the coronary artery to keep it from migrating.Reason for use: cad, old myocardial infarction, angina.

• Brand Name: SPRINTER 3.0 MM X 12 MM BALLOON
• Type of Device: RAPID EXCHANGE BALLOON DILATION CATH
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 5207823
• MDR Text Key: 30701170
• Report Number: MW5057726
• Device Sequence Number: 1
• Product Code: LOX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2017
• Device Model Number: SPL30012X
• Device Catalogue Number: SPL30012X
• Device Lot Number: 209048873
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/04/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 101