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	03/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician was attempting to use a sprinter over the wire balloon catheter to treat a severely calcified vessel.It was reported that the balloon ruptured when inflated.The balloon was removed intact following rupture.No adverse outcome to patient.
Additional Manufacturer Narrative
The device was inspected before use with no issues.Negative prep/purging was performed prior to use with no issues noted.The device was being used to pre-dilate the lesion.Resistance was noted while advancing the device to the lesion due to the calcification.No excessive force was used.No drop in pressure noted on the inflation device.The burst occurred on subsequent inflation.The physician completed the procedure.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: 6597249
• Report Number: 9612164-2017-00638
• Device Sequence Number: 13688917
• 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): 06/28/2017

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: 08/18/2018
• Device Catalogue Number: SPR1512W
• Device Lot Number: 0008184928
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/02/2017
• Supplement Date Received by Manufacturer: 06/28/2017
• Initial Report FDA Received Date: 05/30/2017
• Supplement Report FDA Received Date: 07/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR