MAUDE Adverse Event Report: MEDTRONIC IRELAND SPRINTER OTW; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Catalog Number	SPR1512W
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
The physician attempted to use a sprinter otw balloon catheter to treat a heavily calcified lesion in the rca.The balloon was flushed and prepped prior to use.Resistance was noted when advancing the device due to previous isr and heavy calcification.The balloon was inserted into the vessel.On the third inflation of 14 atm for 6 seconds (1520pm), the balloon burst.The balloon rupture occurred at nominal pressure.The balloon was removed from the patient and examined to ensure all material was accounted for and none was left in the vessel.Subsequent balloon sizes were used to open the isr.The procedure was completed with a stent in stent.No adverse patient effect occurred and the patient is reported to be good.A euphora balloon was also used.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPRINTER OTW
• Common Device Name: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7221016
• Report Number: 9612164-2018-00150
• Device Sequence Number: 2379030
• Product Code: LOX
• UDI-Device Identifier: 00885074197012
• UDI-Public: 00885074197012
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P790017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2019
• Device Catalogue Number: SPR1512W
• Device Lot Number: 0008861754
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/05/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 01/26/2018
• Supplement Report FDA Received Date: 06/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR