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

Catalog Number	SPL12510WL
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Codes	Occlusion (1984); No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688); Vascular Dissection (3160)
Date of Event	10/24/2018
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
An attempt was made to use one sprinter legend otw ptca balloon catheter to treat a lesion in the lad.It was reported that a balloon rupture occurred.
Additional Manufacturer Narrative
The target lesion was moderately calcified.The balloon was inspected and negative prep was performed prior to use with no issue noted.There was some degree of resistance in advancing the balloon catheter across the lesion.Excessive force was not used.The balloon rupture occurred during first inflation at nominal pressure.The device was not moved or repositioned in the lesion prior to the rupture.Blood was noted in the indeflator when device when placed on negative pressure.Dissection of the lad was noted after the inflation.Loss of flow was noted and the decision was made to place an iabp and send the patient to the or for bypass, given that the lesion could not be dilated.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPRINTER LEGEND 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: 8105592
• Report Number: 9612164-2018-03366
• Device Sequence Number: 16634588
• Product Code: LOX
• UDI-Device Identifier: 00643169854949
• UDI-Public: 00643169854949
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K103095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2019

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: 06/03/2021
• Device Catalogue Number: SPL12510WL
• Device Lot Number: 215588453
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 11/29/2018; 01/29/2019
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 12/17/2018; 01/30/2019
• 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: 73 YR
• Patient Weight: 56