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

Catalog Number	SPR1512W
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	Injury (2348); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a ptca procedure an attempt was made to use a sprinter otw ptca balloon catheter to pre-dilate the left obtuse marginal.The left coronary system was noted to be heavily calcified.The sprinter balloon was advanced over a 0.14 coronary wire.It was reported that when an attempt was made to pre-dilate the first obtuse marginal a balloon rupture and fragmentation occurred.Multiple attempts were unsuccessful in freeing the retained portion of the trapped balloon.The fragment was then stented against the vessel wall.The vessel was then re-vascularized.The patient was reported to be doing well post procedure.
Additional Manufacturer Narrative
The device was inspected before use with no issues noted.Resistance was not encountered while advancing the device to the lesion.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 MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 9265602
• Report Number: 9612164-2019-04587
• Device Sequence Number: 2616354
• Product Code: LOX
• UDI-Device Identifier: 00643169850330
• UDI-Public: 00643169850330
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/26/2020
• Device Catalogue Number: SPR1512W
• Device Lot Number: 216680462
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR